Noninflammatory Lesion Counts Research Articles

The safety and efficacy of four different fixed combination regimens of adapalene 0.1%/benzoyl peroxide 2.5% gel for the treatment of acne vulgaris: results from a randomised controlled study.

Combined use of a retinoid and antimicrobial is recommended for acne, however, local tolerability issues may compromise patient adherence and treatment outcome. This multicentre, single-blinded controlled study was designed to determine whether modified adapalene/benzoyl peroxide (A/BPO, Epiduo®, Galderma, France) regimens improve local tolerability during the first four weeks of treatment without impairing efficacy at Week 12. In total, 120 subjects with mild-to-moderate acne received, during the first four weeks, A/BPO daily overnight (A/BPO-EN), A/BPO daily for three hours (A/BPO-3h), A/BPO daily overnight and a provided moisturizer lotion (A/BPO-moisturizer), or A/BPO every other night (A/BPO-EoN). Local tolerance assessments included signs and symptoms, global worst score (GWS), and total sum score (TSS). Efficacy was assessed based on lesion counts, investigator global assessment (IGA), and total lesion count reduction. Adherence, subject satisfaction, and overall safety were also assessed. The mean TSS was significantly reduced at Week 1 with A/BPO-EoN vs. A/BPO-EN (p<0.05), and A/BPO-EoN led to the lowest GWS and a decrease in severity of stinging/burning and erythema (p<0.05). The A/BPO-moisturizer regimen prevented dryness and scaling compared with the A/BPO-EN regimen. The median decrease in lesions from baseline was similar in all groups: up to 67% for total, 72% for inflammatory, and 70% for non-inflammatory lesion counts. Adherence, IGA, patient satisfaction, and overall safety were excellent. Modulating treatment regimens during the first four weeks improved local tolerability without impacting overall efficacy outcome after 12 weeks and may improve treatment adherence during the first weeks of therapy.

Efficacy and tolerability of a lotion containing triethyl citrate, ethyl linoleate, and GT peptide-10 in the adjuvant treatment of hidradenitis suppurativa: Real-life data.

Hidradenitis suppurativa (HS) is a chronic disorder of terminal follicular epithelium in the apocrine gland-bearing areas. The long term therapy is based mainly on topical and/or systemic antibiotic use that could result in antibiotic resistance. The aim of our study was to present the real-life experience based on the efficacy and tolerability of a novel lotion containing triethyl-citrate, ethyl-linoleate, and g-peptide-10 in the treatment of mild to moderate HS that has already shown effectiveness in acne treatment. This was an open-label study on 30 patients of both sexes affected by HS. Patients were divided into two groups: 15 with Hurley I and 15 with Hurley II-III. The subjects were treated with the topical lotion, three-times-daily for eight weeks, with control at 4 (T1 ) and eight weeks (T2 ). Any other concomitant treatment (both topical and/or systemic) was avoided during study period. Improvement was observed in both Sartorius score grading system and inflammatory and noninflammatory lesion counts. The novel lotion has proved to be effective and well-tolerated topical agent alone or in association with other topical and/or systemic tratments in HS, without side effects.

A comparison study of the clinical efficacy and safety of topical adapalene gel (0.1%) and tretinoin cream (0.025%) in the treatment of acne vulgaris

Background: Adapalene a synthetic retinoid analogue, is an addition to the arsenal of topical retinoids developed for the topical treatment of acne vulgaris. The study was designed to compare the clinical efficacy and safety of topical adapalene gel 0.1% and tretinoin cream 0.025% in the treatment of acne vulgaris. Methods: A total of 80 patients with grade I-III acne vulgaris seen in the out-patient department of a tertiary care center were randomized to 8 weeks of daily treatment with either adapalene gel 0.1% or tretinoin gel 0.025%. Counts of total lesions, inflammatory lesions and non-inflammatory lesions were made at baseline and again at treatment weeks 2, 4, 6 and 8. Global assessment ratings, based on percent lesion reduction from baseline were also made. Side-effects like erythema, burning, pruritus, scaling and dryness were rated on a 0-3 severity scale. Results: Out of 80 patients there were 8 dropouts in the study; the 72 patients who completed the study were evaluated for efficacy and safety. Both adapalene and tretinoin produce dramatic reductions in total, inflammatory and non-inflammatory lesion counts, on an average. Cutaneous side-effects were limited to a mild retinoid dermatitis occurring in both treatment groups however patients treated with adapalene gel tolerated this therapy significantly better than those treated with tretinoin cream. Conclusions: Adapalene gel 0.1% offers comparable efficacy to tretinoin cream 0.025 % cream, but is less irritating. Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients.

Comparison of efficacy and safety of adapalene and benzoyl peroxide-clindamycin combination in the topical treatment of acne vulgaris

Background: Acne vulgaris is a dermatological disorder characterised by formation of comedones and inflammatory lesions. The treatment of acne basically involves reduction of lesions and prevention of permanent scarring. The current line of treatment for mild to moderate acne is topical medications with antimicrobials and retinoids. The present study assessed the efficacy and safety of adapalene in comparison to benzoyl peroxide-clindamycin combination that whether it is better than the benzoyl peroxide-clindamycin combination for topical treatment of mild to moderate acne vulgaris.Methods: In this study, the patients with mild to moderate acne vulgaris were divided into two groups, one group was treated with topical adapalene whereas topical benzoyl peroxide-clindamycin combination was given to the other group. Assessment of efficacy was done by total lesion counting while safety assessment was done by noting the adverse drug reactions due to medication, the results were compared at the end of 1, 2 and 3 months with the baseline values.Results: At the end of this study, it was found that the reduction of non-inflammatory, inflammatory and total lesion counts from baseline were highly significant in both the groups (p&lt;0.0001), but between the groups, differences were not significant statistically (p&gt;0.05), therefore adapalene and benzoyl peroxide-clindamycin combination were found to have similar efficacy. The tolerability profile of adapalene was comparatively better than benzoyl peroxide-clindamycin combination.Conclusions: Adapalene is as efficacious as benzoyl peroxide-clindamycin combination to treat mild to moderate acne vulgaris, but it is comparatively better tolerated than benzoyl peroxide-clindamycin combination.

Novel retinoid ester in combination with salicylic acid for the treatment of acne.

Retinoids (RC), alpha-hydroxy acids (AHA), and salicylic acid (BHA) treat acne through differing mechanisms of action. It is theorized that optimal improvement can be achieved by combining the RC-induced normalization of cellular differentiation, AHA-induced exfoliation in hydrophilic areas, and BHA-induced exfoliation in lipophilic areas. AHA and RC have been combined in a bioengineered molecule (AHA retinoid conjugate, or AHA-RC) delivering both lactic acid (AHA) and RC in a manner reducing retinoid-associated irritation. To evaluate efficacy and tolerability of a twice-daily, three-product skincare regimen using AHA-RC in combination with BHA for patients with acne. A total of 27 women (age range 20-58 years, mean 37.81 ± 10.04 years) with mild-to-moderate acne used a 3-product regimen consisting of a twice-daily cleanser and topical serum (0.1% AHA-RC, 2% salicylic acid, and 10.4% l-lactic acid), with broad-spectrum SPF 50+ sunscreen as needed, over an 8-week period. Counts were made at baseline, week 4, and week 8 of total inflammatory (papules, pustules) and noninflammatory (open comedones, closed comedones) lesions. Dryness, stinging, and other secondary endpoints were rated on a 0-5 scale. Statistically significant reduction in inflammatory and noninflammatory lesion counts (P = 0.006 and P = 0.015, respectively) was noted at 4 weeks. Improvement continued into week 8 with highly significant (P < 0.001) reductions in both lesion counts. The topical combination of lactic acid, SA, and AHA-RC produced acne improvement after 4 weeks with continuing cumulative improvement at 8 weeks. AHA-RC represents a new molecule combining several mechanisms of action to achieve acne improvement.

Reduction of Inflammatory and Noninflammatory Lesions with Topical Tyrothricin 0.1% in the Treatment of Mild to Severe Acne Papulopustulosa: A Randomized Controlled Clinical Trial

Background/Aims: Antibiotic-induced drug resistance requires new approaches in topical acne treatment. Tyrothricin is known to produce no resistance. In this study, it was tested for the first time in topical acne treatment. The efficacy and tolerability of topical tyrothricin 0.1% was evaluated. Methods: A randomized, active comparator-controlled, exploratory, observer-blind clinical study was conducted in 24 patients with acne papulopustulosa. Randomization on a split-face was either tyrothricin versus clindamycin + benzoyl peroxide (BPO) (n = 12) or tyrothricin versus BPO 5% (n = 12). The main outcome was change in inflammatory and noninflammatory lesion counts. Results: The mean differences in inflammatory lesion counts from baseline were -12.3 (95% CI: -20.5 to -4.1) in clindamycin + BPO, -10.2 (95% CI: -15.3 to -5.0) in BPO 5%, and -7.7 (95% CI: -11.7 to -3.7) in tyrothricin. Tyrothricin reduced noninflammatory lesions (mean difference: -6.5 (95% CI: -11.6 to -1.4) and caused less product-related adverse events (n = 31) compared to BPO (n = 37) and clindamycin + BPO (n = 20). Conclusion: The results indicate that tyrothricin might be a candidate for treating acne and it seems to be more tolerable than both comparator treatments.

Comparative study between topical clindamycin solution (1%) versus combination of clindamycin (1%)/adapalene (0.1%) gel in the treatment of mild to moderate acne vulgaris

Background and objective: Acne vulgaris is a common skin disorder. Combination therapy with topical retinoid and antibiotic is recognized as an effective treatment of acne vulgaris. The aim of this study was to compare the efficacy and tolerability of topical clindamycin solution as a monotherapy with the combination gel of clindamycin/adapalene for the treatment of mild to moderate acne of the face. Methods: This comparative therapeutic trial was conducted at the out patient department of Dermatology and Venereology at Rizgari Teaching Hospital in Erbil City from November 2008. Hundred patients with mild to moderate acne of the face were enrolled in the study and were divided in to two groups; group I (n=50); apply clindamycin phosphate solution 1%, and group II (n=50); apply a combination gel of clindamycin1% /adapalene 0.1%; once daily at night for 12 weeks. Results: Of 100 patients, 89 patients completed their treatment as per protocol, 45 patients in group I, and 44 patients in group II. At the end of the 12 weeks; the mean percent reductions of noninflammatory, inflammatory, and total lesion count were greater in group II than in group I. A significantly greater reduction of total (P = 0.008), and noninflammatory lesions (P = 0.002) were seen in group II than in group I. Both treatments were well tolerated, and few side effects were reported. Conclusion: This study demonstrates that the combination of topical clindamycin and adapalene is more effective than clindamycin solution alone, and provides faster benefit in treatment of mild to moderate acne.

Complementary therapies for acne vulgaris.

Complementary therapies for acne vulgaris.

Topical epidermal growth factor for the improvement of acne lesions: a randomized, double-blinded, placebo-controlled, split-face trial.

Acne is one of the most common adverse events associated with the use of anticancer agents, such as epidermal growth factor receptor (EGFR) inhibitors. Based on data from several previous reports, we predicted that topical application of EGF could improve acne vulgaris. To evaluate the clinical efficacy and safety of topical recombinant human EGF (rhEGF) cream for the treatment of facial acne vulgaris. Twenty Korean adults with mild to moderate acne vulgaris applied topical rhEGF cream on one half of the face and a vehicle cream on the other half twice daily for sixweeks. Clinical assessments were conducted at baseline, two, four, and sixweeks. Two assessment methods were applied: inflammatory and non-inflammatory acne lesion counts and acne severity score by investigator's global assessment. Skin sebum output level and hydration level were also measured at each visit. All volunteers completed the study. At the final visit, inflammatory acne lesions were reduced by 33.5% on the rhEGF-applied side. Non-inflammatory acne lesions also decreased by 25.4%, whereas the lesions on the control side increased. The majority of patients demonstrated improvement on the side of the face where rhEGF cream was applied. Sebum output decreased on the rhEGF side, and skin hydration level increased on both sides. No severe side effects were observed during the study. Topical rhEGF seems to be an effective and safe adjuvant treatment option for mild to moderate acne vulgaris.

Efficacy and tolerability of topical fixed combination of nadifloxacin 1% and adapalene 0.1% in the treatment of mild to moderate acne vulgaris in indian patients: A multicenter, open-labelled, prospective study

Background:A combination of topical retinoid and antibacterial therapy is often advocated for acne to enhance therapeutic efficacy.Aims:A preliminary study to evaluate the efficacy and tolerability of a topical fixed combination of nadifloxacin (1%) and adapalene (0.1%) in the treatment of mild to moderate acne in Indian patients.Materials and Methods:This was an open-labeled, phase 3 non-randomized, non-comparative study conducted at five centers (Ahmedabad, Nagpur, Thane, Bangalore, and Mumbai) across India. Of 119 enrolled patients with mild to moderate acne, 117 patients were evaluated at the end of the study for efficacy parameters. A fixed combination of nadifloxacin (1%) and adapalene (0.1%) topical gel was applied at the affected area once at night for a period of 8 weeks. Reduction in the total, inflammatory and non-inflammatory lesion counts from the baseline, investigator global assessment (IGA) and reduction in the severity of acne as per combined acne severity classification were the primary efficacy variables measured at 2 weeks, 4 weeks, and 8 weeks.Results:Overall, 98.3% patients showed a statistically significant progressive reduction in non-inflammatory lesion counts, inflammatory lesion counts, and total lesion counts over the study duration. By the end of 8 weeks, 75% of the patients had their global assessment scores approaching to normal healthy skin score. The adverse events were mild to moderate in severity.Conclusion:This preliminary study shows that a fixed combination of 1% nadifloxacin and 0.1% adapalene topical gel could be an effective and well-tolerated option for the treatment of mild to moderate acne vulgaris. However, further well-controlled, randomized and comparative evaluation of this combination is necessary.

Efficacy of daily low dose versus intermittent isotretinoin regimens in patients with moderate acne vulgaris: A randomized-controlled trial

Background: Oral isotretinoin, a vitamin A acid derivative, is the most effective treatment of severe acne. As its use is associated with many side effects, low-dose and intermittent application protocols for patients with mild or moderate acne have been reported. Aim: Our purpose was to compare the outcome of two different regimens of low dose isotretinoin; daily versus monthly doses in patients with moderate acne vulgaris. Patients and methods: A randomized controlled trial was conducted on 75 patients with moderate acne vulgaris attending outpatient clinic in the dermatology department at El-Jumhuriya hospital in Benghazi city during the period of June 2009 to June 2011. The patients were randomly assigned to two groups. Group 1 consisted of 45 patients, treated with a daily fixed dose of 20 mg of isotretinoin and group 2 consisted of 30 patients, treated with 20 mg of isotretinoin twice daily for seven days every month. Both groups were treated for a total period of four months. No topical treatments were permitted for both groups. Clinical assessment was done at 0, 4, 8, 12, and 16 weeks, which included acne lesion counts, total acne load, the assessment of severity score of acne and the side effects of the treatment. Patients were followed for six months after stopping treatment. Results: Fifty five patients with moderate acne vulgaris completed the study. Group 1 consisted of 32 patients with equal proportion of females and males; their mean age and standard deviation (SD) was 20.2±4.1 years. Group 2 consisted of 23 patients; 52.2% were females and 47.8% were males, their mean age and SD was 20±3.4 years. No statistically significant difference was observed according to the age and gender among both groups. Acne scores in each group were significantly lower at the end of treatment period. The mean decrease in the inflammatory and non-inflammatory lesion counts was more and earlier in group 1 compared to group 2, this difference was statistically insignificant. Both treatment regimens were well tolerated; cheilitis was the most frequent side-effect seen in 81.3% and 69.6% of patients in group 1 and group 2 respectively. However, there was no statistically significant differences among both groups regarding the frequency and severity of the side effects. The total cumulative dose was significantly higher in group 1 as compared to group 2 (P=0.000). During the follow- up period there was no statistically significant difference between both groups in relapse rate which has been seen in 7 (21.9%) patients in group 1 and 9 (39.1%) patients in group 2. Conclusion: Both isotretinoin regimens were safe and effective treatment for moderate acne vulgaris, however, intermittent sotretinoin regimen may be a cost- effective alternative.

Persistent Effects of Adapalene Gel After Chemical Peeling with Glycolic Acid in Patients with Acne Vulgaris

We investigated the usefulness of adapalene gel as maintenance therapy following chemical peeling with glycolic acid in patients with acne vulgaris. The study period was 14 weeks. The subjects were 23 patients with mild to moderate acne vulgaris (1 male, 22 females). After chemical peeling (CP) of the face was performed 3 times at 2-week intervals, adapalene was applied for 6 weeks using a randomized, double-blind half-side method. On the day of observation, dermatologists examined dermal findings, and measurement was conducted using instruments to analyze the physiological skin function. After the third session of CP was completed, both the inflammatory and non-inflammatory lesion counts significantly decreased. Subsequently, on the adapalene-treated side there were no change in the inflammatory and non-inflammatory lesion counts after the CP 3 times, but on placebo-treated side, there significant increase in the inflammatory and non inflammatory lesion counts. Concerning the results of measurement with instruments, the sebum capacity significantly decreased after the third session of CP. Subsequently, there were no changes after the 6-week application of adapalene or a placebo. These results suggest that post-CP adapalene application is an effective acne treatment method to improve efficacy and treatment adherence.

Effectiveness of photodynamic therapy with topical 5‐aminolevulinic acid and intense pulsed light in Chinese acne vulgaris patients

The success rates of conventional treatments to acne vulgaris are limited because of intolerance and resistance. Photodynamic therapy with topical 5-aminolevulinic acid (ALA) and red light has been introduced. However, the side effects especially pigmentation are common. To study the efficacy and safety of ALA-photodynamic therapy (PDT) with 420-950 nm intense pulsed light (IPL) in Chinese patients with acne vulgaris. Forty-one patients with moderate to severe facial acne were randomly assigned to ALA-IPL-PDT group and IPL group. Ten percent topical ALA was applied to patients in the ALA-IPL-PDT group, while placebos were applied to patients in the IPL group. After 1 h occlusion, all patients were illuminated with 420-950 nm IPL. The patients in both groups had four treatment sessions with 1-week intervals. One week after each treatment and 4, 8, and 12 weeks after four sessions, acne lesion counts and adverse events were observed. Twelve weeks after treatments, mean reductions of global lesion counts of ALA-IPL-PDT group and IPL group were 75.2% and 51.0%, respectively. Mean reductions of inflammatory and non-inflammatory lesion counts in ALA-IPL-PDT group were (83.6 ± 4.1)% and (57.5 ± 6.8)%, respectively. No severe adverse events were observed. ALA-IPL-PDT is an effective treatment for moderate to severe acne vulgaris, and side effects are mild and reversible.

Salicylic Acid Peels Versus Jessner's Solution for Acne Vulgaris: A Comparative Study

Salicylic acid was recently formulated in a hydroethanolic vehicle at a concentration of 20% to 30%. Salicylic acid has strong comedolytic effects because of its lipophilic nature. To compare the therapeutic efficacy and tolerability of salicylic acid peels with those of Jessner's solution peels in patients with acne vulgaris. Thirteen patients (13 men; mean age 22.6, range 20-28) with facial acne were enrolled. Jessner's solution was applied to one side of each patient's face and 30% salicylic acid to the other in three sessions at 2-week intervals. A blinded investigator counted noninflammatory and inflammatory lesions before treatment and 2weeks after each treatment. Inflammatory and noninflammatory acne lesion counts decreased in proportion to the duration of treatment. Inflammatory acne lesion counts did not differ significantly between salicylic acid and Jessner's solution peels, although in terms of noninflammatory acne lesion counts, sites treated with salicylic acid showed significant improvement (p=.04), whereas those treated with Jessner's solution did not. We found that 30% salicylic acid peels were effective for inflammatory acne and more effective than Jessner's solution peels for treating noninflammatory acne.

Combined oral contraceptive pills for treatment of acne.

Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. In January 2012, we searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) (Aug 2011). For the initial review, we wrote to researchers to seek any unpublished or published trials that we might have missed. We considered randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women. We extracted data on facial lesion counts, both total and specific (i.e., open or closed comedones, papules, pustules and nodules); acne severity grades; global assessments by the clinician or the participant, and discontinuation due to adverse events. Data were entered and analyzed in RevMan. For continuous data, we calculated the mean difference (MD) and 95% confidence interval (CI). For dichotomous data, we calculated the Peto odds ratio (OR) and 95% CI. The review includes 31 trials with 12,579 participants. Of 24 comparisons made, 6 compared a COC to placebo, 17 different COCs, and 1 compared a COC to an antibiotic. Of nine placebo-controlled trials with data for analysis, all showed COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. A levonorgestrel-COC group had fewer total lesion counts (MD -9.98; 95% CI -16.51 to -3.45), inflammatory and non-inflammatory lesion counts, and were more likely to have a clinician assessment of clear or almost clear lesions and participant self-assessment of improved acne lesions. A norethindrone acetate COC had better results for clinician global assessment of no acne to mild acne (OR 1.86; 95% CI 1.32 to 2.62). In two combined trials, a norgestimate COC showed reduced total lesion counts (MD-9.32; 95% CI -14.19 to -4.45), reduced inflammatory lesion and comedones counts, and more with clinician assessment of improved acne. For two combined trials of a drospirenone COC, the investigators' assessment of clear or almost clear skin favored the drospirenone group (OR 3.02; 95% CI 1.99 to 4.59). In one trial, the drospirenone-COC group showed greater (more positive) percent changes for total lesion count (MD 29.08; 95% CI 3.13 to 55.03), inflammatory and non-inflammatory lesion counts, and papule and closed comedone counts. A dienogest-COC group had greater percentage decreases in total lesion count (MD -15.30; 95% CI -19.98 to -10.62) and inflammatory lesion count, and more women assessed with overall improvement of facial acne. A CMA-COC group had more 'responders,' those with 50% or greater decrease in facial papules and pustules (OR 2.31; 95% CI 1.50 to 3.55)Differences in the comparative effectiveness of COCs containing varying progestin types and dosages were less clear, and data were limited for any particular comparison. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel. A COC with cyproterone acetate showed better acne outcomes than one with desogestrel, but the studies produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes, but results were not consistent. A drospirenone COC appeared to be more effective than norgestimate or nomegestrol acetate plus 17β-estradiol but less effective than cyproterone acetate. This update yielded six new trials but no change in conclusions. The six COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important and consistent differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since only one trial addressed this issue. The use of standardized methods for assessing acne severity would help in synthesizing results across trials as well as aid in interpretation.

Low intrinsic drug activity and dominant vehicle (placebo) effect in the topical treatment of acne vulgaris

In drug treatment for acne, topical products alone or in combination with systemic products are commonly prescribed. It was recently pointed out by Chiou that oral tetracyclines, the most commonly prescribed systemic drugs, may not be as effective as commonly assumed because the effect of placebo can approach drug effects during the 4 - 12 weeks of daily administration. The present work evaluated the percent contribution of vehicle (placebo) toward the reported efficacy of reduction in total (inflammatory and non-inflammatory) lesion counts of 8 commonly prescribed topical preparations at the end of 10 - 12 weeks of daily administration. These preparations included 0.1% tretinoin, 0.1% adapalene, 5% dapsone, 1% clindamycin, a combination of benzoyl peroxide with adapalene or clindamycin, and a clindamycin-tretinoin combination. The mean reduction from drugs and vehicles were 42 ± 7.1%, and 23 ± 5.0%, respectively; the mean contribution of vehicle toward drug effect was 55 ± 15% (range 35 - 82%). For 5 benzoyl peroxide preparations evaluated (2 for 2.5%, and 3 for 5.0%), their respective means were 40 ± 9%, and 25 ± 15%, and vehicle-toward-drug contribution was 58 ± 31% (range 9 - 89%). The present work shows the great importance of vehicle effects in topical therapy; in some cases this effect approached 90%. The potential significance of the above findings in the development of more effective topical anti-acne drugs was discussed.

Selective sebaceous gland electrothermolysis as a treatment for acne: a prospective pilot study

Although many therapeutic options exist for acne, relapse often occurs after treatment is stopped. Some preliminary evidence suggests that selective electrothermolysis of the sebaceous glands may represent a novel therapeutic intervention. This trial was conducted to evaluate the efficacy and tolerability of selective sebaceous gland electrothermolysis for the treatment of facial acne. Twelve patients with facial acne were enrolled, all of whom underwent three sessions of therapy. During each session, a 1.5-mm long needle with 0.45-mm of base insulation was inserted into pores of acne lesions. Upon insertion, a high-frequency electrical current was applied for 0.25-0.50 seconds, for a total output of 40 W. Each treatment session took approximately 30-60 minutes. Subject response to therapy was evaluated at one month and 12 months after the final treatment. All the enrolled subjects completed the study and all reported satisfaction with treatment results. In all cases, a reduction in inflammatory and noninflammatory lesion counts was observed after three sessions of selective electrothermolysis, although a few small papules and comedones persisted in several areas of untreated facial skin. Mean lesion reduction at one month after the final treatment was 98.14% for inflammatory lesions and 83.09% for noninflammatory lesions. Clinical success was achieved in the majority of patients (seven of 12 patients) at one month after the second treatment and in all patients at one month after the final treatment. All patients reported transient post-treatment erythema, which faded after a few days. Clinically evident relapse occurred in two of 12 patients (16.7%) one year after the final treatment session. Selective sebaceous gland electrothermolysis can be a safe and effective method of achieving consistent remission in acne.

Efficacy and safety of a nano-emulsion gel formulation of adapalene 0.1% and clindamycin 1% combination in acne vulgaris: A randomized, open label, active-controlled, multicentric, phase IV clinical trial

Acne vulgaris is a very common skin disease with a significant detrimental effect on the quality of life of the patients. To assess the comparative efficacy and safety of a nano-emulsion gel formulation of adapalene and clindamycin combination with its conventional formulation in the treatment of acne vulgaris of the face. It was a prospective, randomized, open label, active-controlled, multicentric, clinical trial. Eligible patients suffering from acne vulgaris of the face were randomized to receive once-daily treatment with a nano-emulsion gel or conventional gel formulation of adapalene 0.1% and clindamycin (as phosphate) 1% combination for 12 weeks. Total, inflammatory and noninflammatory lesion counts, with grading of acne severity were carried out on a monthly basis. Safety assessments were done to determine the comparative local and systemic tolerability. Two-tailed significance testing was carried out with appropriate statistical tests, and P-values < 0.05 were considered as significant. 209/212 patients enrolled in the study were eligible for efficacy and safety assessments in both nano-emulsion gel (118/119 patients) and conventional gel (91/93 patients) groups. Significantly better reductions in total (79.7% vs. 62.7%), inflammatory (88.7% vs. 71.4%) and noninflammatory (74.9% vs. 58.4%) lesions were reported with the nano-emulsion gel as compared to the conventional gel (P < 0.001 for all). Mean acne severity score also reduced significantly more with the nano-emulsion formulation (1.9 ± 0.9 vs. 1.4 ± 1.0; P < 0.001) than the comparator. Significantly lower incidence and lesser intensity of adverse events like local irritation (4.2% vs. 19.8%; P < 0.05) and erythema (0.8% vs. 9.9%; P < 0.05) were recorded with the nano-emulsion gel. The nano-emulsion gel formulation of adapalene and clindamycin combination appears to be more efficacious and better tolerated than the conventional formulation for the treatment of acne vulgaris in Indian patients. Further studies can elucidate the comparative treatment benefits of this nano-emulsion gel formulation.

Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel

Adapalene 0.1%/benzoyl peroxide 2.5% gel (Epiduo™, Tactuo™) is the only fixed-dose combination product available that combines a topical retinoid with benzoyl peroxide; it targets three of the four main pathophysiologic factors in acne. This article reviews the therapeutic efficacy and tolerability of topical adapalene 0.1%/benzoyl peroxide 2.5% gel in the treatment of patients aged ≥ 12 years with acne vulgaris, as well as summarizing its pharmacologic properties. In three 12-week trials in patients aged ≥ 12 years with moderate acne, success rates were significantly higher with adapalene 0.1%/benzoyl peroxide 2.5% gel than with adapalene 0.1% gel or benzoyl peroxide 2.5% gel alone, and combination therapy had an earlier onset of action. In addition, significantly greater reductions in total, inflammatory, and noninflammatory lesion counts were seen in patients receiving adapalene 0.1%/benzoyl peroxide 2.5% gel than in those receiving adapalene 0.1% gel or benzoyl peroxide 2.5% gel alone. Adapalene 0.1%/benzoyl peroxide 2.5% gel did not significantly differ from clindamycin 1%/benzoyl peroxide 5% gel in terms of the reduction in the inflammatory, noninflammatory, or total lesion counts in patients with mild to moderate acne, according to the results of a 12-week trial. Twelve-week studies showed that topical adapalene 0.1%/benzoyl peroxide 2.5% gel in combination with oral lymecycline was more effective than oral lymecycline alone in patients with moderate to severe acne, and topical adapalene 0.1%/benzoyl peroxide 2.5% gel in combination with oral doxycycline hyclate was more effective than oral doxycycline hyclate alone in patients with severe acne. In patients with severe acne who responded to 12 weeks' therapy with topical adapalene 0.1%/benzoyl peroxide 2.5% gel plus oral doxycycline hyclate or oral doxycycline hyclate alone, an additional 6 months' therapy with adapalene 0.1%/benzoyl peroxide 2.5% gel was more effective than vehicle gel at maintaining response, with further improvement seen in adapalene 0.1%/benzoyl peroxide 2.5% gel recipients. A noncomparative study also demonstrated the efficacy of 12 months' therapy with adapalene 0.1%/benzoyl peroxide 2.5% gel in patients with acne vulgaris. Topical adapalene 0.1%/benzoyl peroxide 2.5% gel was generally well tolerated in patients with acne. In 12-week trials, the most commonly occurring treatment-related adverse events included erythema, scaling, dryness, and stinging/burning; these dermatologic treatment-related adverse events were usually of mild to moderate severity, occurred early in the course of treatment, and resolved without residual effects. Topical adapalene 0.1%/benzoyl peroxide 2.5% gel was generally well tolerated in the longer term, with dry skin being the most commonly occurring treatment-related adverse event over 12 months of treatment. In conclusion, adapalene 0.1%/benzoyl peroxide 2.5% gel is a valuable agent for the first-line treatment of acne vulgaris.

Efficacy of the addition of salicylic acid to clindamycin and benzoyl peroxide combination for acne vulgaris

Clindamycin phosphate (CDP), benzoyl peroxide (BPO) and salicylic acid (SA) are known to be effective acne therapy agents depending on their anti-inflammatory and comedolytic properties. The purpose of this study was to investigate the efficacy and tolerability of the addition of SA treatment to CDP and BPO (SA and CDP + BPO) and compare it with CDP + BPO in patients with mild to moderate facial acne vulgaris. Forty-nine patients were enrolled in a 12 week prospective, single-blind, randomized, comparative clinical study. Efficacy was assessed by lesion counts, global improvement, quality of life index and measurements of skin barrier functions. Local side effects were also evaluated. Both combinations were effective in reducing total lesion (TL), inflammatory lesion (IL) and non-inflammatory lesion (NIL) counts. There were statistically significant differences between treatment groups for reductions in NIL counts beyond 2 weeks, IL counts and TL counts throughout the all study weeks, and global improvement scores evaluated by patients and investigator at the end of the study in favor of SA and CDP + BPO treatment when compared to CDP + BPO treatment. Both combinations significantly decreased stratum corneum hydration, although skin sebum values decreased with SA and CDP + BPO treatment. These combinations were also well tolerated except significantly higher frequency of mild to moderate transient dryness in patients applied SA and CDP + BPO. The addition of SA to CDP + BPO treatment demonstrated significantly better and faster results in terms of reductions in acne lesion counts and well tolerated except for higher frequency of mild to moderate transient dryness.