Noninflammatory Lesion Counts Research Articles

Tazarotene 0.1 percent cream plus clindamycin 1 percent gel versus tretinoin 0.025 percent gel plus clindamycin 1 percent gel in the treatment of facial acne vulgaris

Topical retinoids are the cornerstone of therapy for acne vulgaris. Nevertheless, the adjunctive use of other anti-acne agents can help enhance the efficacy of topical retinoids still further. Given that tazarotene 0.1 percent gel has previously shown significantly greater efficacy than tretinoin 0.025 percent gel, it is likely that tazarotene plus clindamycin offers superior efficacy to tretinoin plus clindamycin, which has recently become available as a combination product. A total of 150 patients with facial acne vulgaris were randomly assigned to receive either tazarotene 0.1 percent cream plus clindamycin 1 percent gel, or tretinoin 0.025 percent gel plus clindamycin 1 percent gel. Each medication was applied once daily in the evening (clindamycin followed by the retinoid 5-10 minutes later) for up to 12 weeks. At week 12, the reduction from baseline in lesion counts was greater with tazarotene/clindamycin than tretinoin/clindamycin for both the non-inflammatory lesion count (71% vs. 52%, p< or =.01) and the inflammatory lesion count (77% vs. 67%, P=.053). Tazarotene/clindamycin also resulted in a significantly higher incidence of patients achieving > or = 50 percent global improvement (incidence of 88% vs. 75% at week 12; p< or =.05). Both regimens were similarly well tolerated. In the treatment of facial acne vulgaris, tazarotene plus clindamycin offers significantly greater efficacy than tretinoin plus clindamycin and has comparable tolerability.

A pilot study of the safety and efficacy of picolinic acid gel in the treatment of acne vulgaris

Cost limitations, adverse effects or lack of efficacy limit the use of current topical therapies in mild to moderate acne vulgaris. To determine the safety and efficacy of picolinic acid, a novel zinc finger therapy, in the treatment of mild to moderate acne vulgaris. Twenty subjects with mild to moderate acne vulgaris were treated at our centre during an open-label study with 10% picolinic acid gel (PCL-016) twice daily to the face over 12 weeks. Fifteen patients completed the 12-week open-label study. A reduction of 58.2% (P < 0.001) in mean total lesion count, 55.5% (P < 0.001) in mean inflammatory lesion count and 59.7% (P < 0.005) in noninflammatory lesion count was seen in this population. No serious adverse events or clinically significant changes in laboratory values were noted. Results from this study suggest that 10% picolinic acid gel applied twice daily may be safe and effective in the treatment of mild to moderate acne vulgaris.

Reliability of Dermatologists in Acne Lesion Counts and Global Assessments

There is a paucity of data on the reliability of dermatologists in acne lesion counting and global severity assessments. The effects of training and practice on reliability are also uncertain. The objective of this study was to determine the reliability of these outcome measurements when performed by trained dermatologists. Eleven dermatologists were divided into two groups that evaluated the same six acne subjects twice on the same day. A training session was provided either after (group A) or before (group B) the first patient evaluation sessions. Reliability of raters in lesion counting and global severity assessment was determined by calculation of intraclass correlation coefficients (ICCs). ICC values close to 1.0 indicate excellent reliability, whereas values less than 0.75 are considered unacceptable. Intrarater ICCs ranged from 0.37 to 0.99 for noninflammatory lesions, 0.26 to 0.97 for inflammatory lesions, and 0.56 to 0.83 for global assessments for group A (trained after); corresponding values for group B (trained before) were 0.84 to 0.98, 0.61 to 0.95, and 0.43 to 0.91. ICC values >or= 0.75 for all three outcome parameters were observed in one of six group A and three of five group B raters. Interrater ICCs for groups A and B after the first evaluation session were 0.17 versus 0.68 for noninflammatory counts, 0.84 versus 0.72 for inflammatory counts, and 0.71 versus 0.65 for global assessments, respectively. Corresponding values after session 2 were 0.79 and 0.77 for noninflammatory, 0.81 and 0.90 for inflammatory, and 0.61 and 0.77 for global assessments. Dermatologists tended to be reliable in acne lesion counting but somewhat less so in global assessments. Training tended to improve group reliability in noninflammatory lesion counts and increased the proportion of raters with good reliability in all three outcome measures. Practice enhanced reliability in all outcome measurements.

Comparison of Tazarotene and Minocycline Maintenance Therapies in Acne Vulgaris

To evaluate the efficacy of 3 maintenance regimens (topical tazarotene, oral minocycline hydrochloride, or both) in sustaining improvement in acne. Multicenter, open-label treatment phase followed by double-blind, randomized, parallel-group maintenance phase. Ambulatory patients in research or referral centers. Volunteer sample of 189 patients with moderately severe to severe acne vulgaris (110 entered maintenance phase, 90 completed, and 2 discontinued because of adverse events). All patients were treated with 0.1% tazarotene gel (each evening) and a 100-mg capsule (twice daily) of minocycline hydrochloride for up to 12 weeks. Patients with 75% or greater global improvement at week 12 were randomly assigned to 12 weeks of maintenance therapy with tazarotene gel plus placebo capsules, vehicle gel plus minocycline capsules, or tazarotene gel plus minocycline capsules. Overall disease severity, global improvement, and lesion counts. All regimens were effective in sustaining improvements in acne. After 12 weeks of maintenance therapy, the mean reductions from baseline in noninflammatory and inflammatory lesion count, respectively, were 60% and 54% with tazarotene, 52% and 66% with minocycline, and 64% and 66% with tazarotene plus minocycline. At week 24, more than 80% of patients in each group had maintained a 50% or greater global improvement from baseline, and more than 50% had maintained a 75% or greater global improvement. A high percentage of patients with moderately severe to severe acne can maintain improvement in their condition with topical retinoid monotherapy. Maintenance with combination tazarotene and minocycline therapy showed a trend for greater efficacy but no statistical significance vs tazarotene alone. Topical retinoid monotherapy should be considered for maintenance to help minimize antibiotic exposure.

Two randomized, double-blind, controlled trials of 2219 subjects to compare the combination clindamycin/tretinoin hydrogel with each agent alone and vehicle for the treatment of acne vulgaris

The development of a hydrogel to stabilize and solubilize clindamycin and tretinoin provides a single, once-daily treatment for acne vulgaris. Our aim was to compare the efficacy and safety of the combination of clindamycin (1%) and tretinoin (0.025%) with each agent alone and vehicle. Two randomized, double-blind, active drug- and vehicle-controlled 12-week studies evaluated inflammatory and noninflammatory lesion counts and the Investigator's Static Global Assessment in 2219 subjects with acne vulgaris. The combination demonstrated superior efficacy to clindamycin, tretinoin, and vehicle. Combination hydrogel was significantly more effective in reducing inflammatory (P < .005), noninflammatory (P < or = .0004), and total (P < .0001) lesion counts than the other treatments and vehicle. The proportion of subjects with clear or almost clear skin on the Investigator's Static Global Assessment was greater with the combination (P < .0001). A majority of subjects (82.6%) had grade 2-3 acne vulgaris at baseline; therefore these overall results may not be representative of the response in the subjects (17.4%) with grade 4-5 acne. The combination clindamycin/tretinoin hydrogel was well tolerated and significantly more effective than clindamycin, tretinoin, or vehicle for the treatment of acne vulgaris.

Treatment of acne with topical antibiotics: lessons from clinical studies

Over the past 20 years, major concerns have been repeatedly expressed over antibiotic-resistant acne in Europe and in the U.S.A. However, the clinical significance of these resistance patterns is poorly defined so that topical antibiotics remain one of the cornerstones of acne management. To determine whether we are facing decreased efficacy of topical formulations of erythromycin and clindamycin in clinical trials of therapeutic interventions for acne. To review systematically the results of the clinical trials investigating topical formulations of erythromycin and clindamycin for the treatment of inflammatory acne and to establish whether or not there is a decrease in the efficacy of these topical antibiotic formulations since their widespread introduction in the mid 1970s. Of the 50 eligible controlled trials identified using a systematic electronic database search strategy, 45 (90%) incorporated a lesion count, making comparison across trials possible. Analysis of clinical studies investigating the effect of topical erythromycin in acne patients indicates a significant decrease in the effect of this antibiotic on inflammatory and noninflammatory lesion count over time (r = -2.140, P = 0.001 and r = -2.032, P = 0.001, respectively). Efficacy of topical clindamycin remained stable during the study period. There is a gradual decrease in the efficacy of topical erythromycin in clinical trials of therapeutic intervention for acne, which is probably related to the development of antibiotic-resistant propionibacteria.

Treatment of acne vulgaris.

Management of acne vulgaris by nondermatologists is increasing. Current understanding of the different presentations of acne allows for individualized treatments and improved outcomes. To review the best evidence available for individualized treatment of acne. Search of MEDLINE, EMBASE, and the Cochrane database to search for all English-language articles on acne treatment from 1966 to 2004. Well-designed randomized controlled trials, meta-analyses, and other systematic reviews are the focus of this article. Acne literature is characterized by a lack of standardization with respect to outcome measures and methods used to grade disease severity. Main outcome measures of 29 randomized double-blind trials that were evaluated included reductions in inflammatory, noninflammatory, and total acne lesion counts. Topical retinoids reduce the number of comedones and inflammatory lesions in the range of 40% to 70%. These agents are the mainstay of therapy in patients with comedones only. Other agents, including topical antimicrobials, oral antibiotics, hormonal therapy (in women), and isotretinoin all yield high response rates. Patients with mild to moderate severity inflammatory acne with papules and pustules should be treated with topical antibiotics combined with retinoids. Oral antibiotics are first-line therapy in patients with moderate to severe inflammatory acne while oral isotretinoin is indicated for severe nodular acne, treatment failures, scarring, frequent relapses, or in cases of severe psychological distress. Long-term topical or oral antibiotic therapy should be avoided when feasible to minimize occurrence of bacterial resistance. Isotretinoin is a powerful teratogen mandating strict precautions for use among women of childbearing age. Acne responses to treatment vary considerably. Frequently more than 1 treatment modality is used concomitantly. Best results are seen when treatments are individualized on the basis of clinical presentation.

An open-label study of the use of adapalene cream and a triple-combination therapy for the treatment of mild-to-moderate acne and post-inflammatory hyperpigmentation

Acne is the most common disorder seen by dermatologists today. In darker skin types (Fitzpatrick IV-VI), post-inflammatory hyperpigmentation (PIH) is a frequent sequel to acne, and may be emotionally devastating to patients. Treatment consists of topical retinoids and antimicrobial agents to address both inflammatory and non-inflammatory acne lesions. The gold standard for treatment for PIH is hydroquinone-containing products that can be used alone or in combination to reverse the pigmentary changes. This 12-week, open-label study examined the use of adapalene cream and a triple-combination depigmenting formulation containing tretinoin, hydroquinone, and fluocinolone acetonide in the treatment of mild-to-moderate acne and PIH. Subjects included 10 patients with skin types IV-VI. Evaluations were made by means of photography and mexameter reading to assess hyperpigmented macules at baseline and at weeks 2,4,8, and 12. The patients used adapalene cream once daily in the morning for 12 weeks and the triple-combination cream once daily in the evening for 8 weeks. Patients were instructed to use a mild cleanser twice daily, a moisturizers with SPF15 once daily in the morning and a moisturizer cream or lotion, as needed. Efficacy endpoints include investigators global assessments, total lesion counts, inflammatory and non-inflammatory lesion counts, and hyperpigmented macules. Safety endpoints include erythema, dyspigmentation, scaling, itching, burning, skin irritation, telangiectasia, and atrophy. Regarding to quality of life, results of a patient survey that scored feelings regarding their treatment, their condition and how it affects various aspects of their life, and rating of their improvement will also be discussed.

A successful maintenance approach in inflammatory acne with adapalene gel 0.1% after an initial treatment in combination with clindamycin topical solution 1% or after monotherapy with clindamycin topical solution 1%

BACKGROUND: METHODS: A total of 300 acne subjects entered this multicentre, randomized, investigator-blinded study comparing the efficacy and safety of adapalene gel 0.1% plus clindamycin topical solution 1% versus clindamycin topical solution 1% alone. In the second part of the study (weeks 12-24), completed by 241 subjects, the efficacy and safety of adapalene gel 0.1% alone as a maintenance therapy was investigated. RESULTS: A statistically significant greater reduction was observed from week 4 until week 12 in total lesion counts and from week 8 on for inflammatory and non-inflammatory lesion counts during the initial treatment for combination therapy compared with monotherapy. Results at week 24 for the reduction in all lesion counts during the maintenance phase were statistically significant in favour of adapalene (41.6%) compared with an increase for all lesion counts in the control group (92.1%). Adapalene alone or in combination with clindamycin topical solution was well tolerated. Few adverse events occurred, all of them during the initial treatment phase. Most of these local events were mild or moderate. CONCLUSION: The present study confirmed the importance of a maintenance therapy after a successful initial treatment and underlined the benefit of a combination therapy with a topical retinoid such as adapalene and a topical antibiotic in the treatment of inflammatory acne.

Salicylic Acid Peels for the Treatment of Acne Vulgaris in Asian Patients

BACKGROUND Salicylic acid peels have been introduced as a useful modality in acne treatment. Few studies have examined its efficacy and safety, especially in darker skin. OBJECTIVE To assess the efficacy and safety of salicylic acid peels as a treatment for acne vulgaris in Asian patients. METHODS Thirty-five Korean patients with facial acne were treated with 30% salicylic acid peels biweekly for 12 weeks. Lesion counts and Dr. Cunliffe's score were assessed by a blinded evaluator. Safety assessments and patient's evaluations were also recorded. RESULTS Both inflammatory and noninflammatory acne lesion counts were decreased in proportion to the duration of treatment. Dr. Cunliffe's acne grade was statistically significantly decreased after treatment. The side effects were tolerable in most cases, and all patients were pleased with their peel results. Stratum corneum hydration, skin surface lipid, skin pH, and transepidermal water loss were unchanged from baseline levels. CONCLUSION Salicylic acid peels are an effective and safe therapy for acne vulgaris in Asian patients.

Is combined oral and topical therapy better than oral therapy alone in patients with moderate to moderately severe acne vulgaris? A comparison of the efficacy and safety of lymecycline plus adapalene gel 0.1%, versus lymecycline plus gel vehicle

This multicenter, randomized, investigator-blinded study compared the efficacy and tolerability of a combination of lymecycline 300 mg/day orally and adapalene topical gel 0.1% (n = 118) to lymecycline 300 mg/day orally plus vehicle gel (n = 124) in patients with moderate to moderately severe acne vulgaris with both inflammatory and noninflammatory lesions. The primary efficacy end point, total lesion count at end point (last observation carried forward), showed a statistically significant difference in favor of the lymecycline plus adapalene group ( P = .0011). The mean decrease in total, inflammatory and noninflammatory lesion counts was significantly greater at end point in the lymecycline plus adapalene group than in the lymecycline plus vehicle group ( P < .01). In addition, a significant difference for inflammatory and total acne lesions was seen sooner in the adapalene plus lymecycline group. In total, 75.5% of patients in the lymecycline plus adapalene group were markedly improved, almost clear or clear of their lesions at week 12, compared with 51.8% of those in the lymecycline plus vehicle group ( P < .001). Local cutaneous tolerance was generally good in both groups, although more patients receiving the lymecycline plus adapalene combination experienced cutaneous reactions than those receiving lymecycline plus vehicle. There are relatively few studies comparing the efficacy of combined oral and topical therapy with either individual therapy alone. This study clearly demonstrates that lymecycline plus adapalene combination treatment resulted in a significantly greater mean decrease in the number of inflammatory, noninflammatory and total lesions than lymecycline plus vehicle and was well tolerated.

Efficacy and tolerability of combined topical treatment of acne vulgaris with adapalene and clindamycin: a multicenter, randomized, investigator-blinded study

This multicenter, randomized, investigator-blinded study investigated the efficacy and tolerability of adapalene gel 0.1% plus clindamycin phosphate lotion 1%, compared with clindamycin plus vehicle for the treatment of mild to moderate acne vulgaris. A total of 249 patients applied clindamycin lotion twice daily and adapalene (125 patients) or vehicle gel (124 patients) once daily for 12 weeks. A significantly greater reduction of total ( P < .001), inflammatory ( P = .004) and noninflammatory lesions ( P < .001) was seen in the clindamycin plus adapalene group than in the clindamycin plus vehicle group. These significant treatment effects were observed as early as week 4 for both noninflammatory and total lesion counts. Both treatment regimens were well tolerated. Although the worst scores for scaling ( P < .05), dryness ( P < .01), and stinging/burning ( P < .05) were higher in the clindamycin plus adapalene group than in the clindamycin plus vehicle group in patients with moderate or severe irritation; in most cases these symptoms were of mild intensity.

A randomized, controlled trial of a low-dose contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel for acne treatment

Objective: To evaluate the efficacy of a low-dose oral contraceptive (OC) containing 100 μg of levonorgestrel (LNG) and 20 μg of ethinyl estradiol (EE) compared with placebo for the treatment of moderate acne. Design: Multicenter, randomized, double-blind, placebo-controlled clinical trial. Setting: Outpatient dermatology clinics. Patient(s): Women (≥14 years old; n = 350) with normal menstrual cycles and moderate acne were randomized to receive LNG/EE or placebo for six cycles. Intervention(s): Twenty μg of EE and 100 μg of LNG. Main Outcome Measure(s): Acne lesion counts and clinician global assessment were performed at baseline and at each cycle. Patient self-assessment was carried out at baseline and at cycles 4 and 6; blood pressure and weight were measured at baseline and at cycles 1, 3, and 6. Result(s): Inflammatory, noninflammatory, and total lesion counts at cycle 6 with LNG/EE were significantly lower compared to placebo. Patients in the LNG/EE group also had significantly better clinician global and patient self-assessment scores than those in the placebo group at cycle. Changes in weight from baseline were similar between patients in the LNG/EE and placebo groups at all measured time points. Conclusion(s): This double-blind, placebo-controlled study demonstrates that a low-dose OC containing 20 μg of EE and 100 μg of LNG is an effective and safe treatment for moderate acne.

Tazarotene versus tretinoin or adapalene in the treatment of acne vulgaris

The efficacy and tolerability of tazarotene 0.1% gel in the treatment of acne vulgaris have been compared with those of tretinoin 0.025% gel and adapalene 0.1% gel in multicenter, double-blind, randomized, parallel-group trials. Preliminary results from the tazarotene versus tretinoin trial suggest that once-daily tazarotene is more efficacious than once-daily tretinoin in reducing the numbers of papules and open comedones, and achieves a more rapid reduction in pustules. Both drugs appear to be equally efficacious against closed comedones. Preliminary results from the tazarotene versus adapalene trial suggest that, when tazarotene is applied only half as frequently as adapalene (every other day versus every day), the two drugs achieve comparable reductions in noninflammatory and inflammatory lesion counts. The results from these studies, and a separate split-face tolerability study, suggest that the tolerability of tazarotene gel is clinically comparable to that of tretinoin 0.025% gel, tretinoin 0.1% gel microsphere, and adapalene 0.1% gel. (J Am Acad Dermatol 2000;43:S51-4.)

Immediate hypersensitivity to permanent hair color

The efficacy and tolerability of tazarotene 0.1% gel in the treatment of acne vulgaris have been compared with those of tretinoin 0.025% gel and adapalene 0.1% gel in multicenter, double-blind, randomized, parallel-group trials. Preliminary results from the tazarotene versus tretinoin trial suggest that once-daily tazarotene is more efficacious than once-daily tretinoin in reducing the numbers of papules and open comedones, and achieves a more rapid reduction in pustules. Both drugs appear to be equally efficacious against closed comedones. Preliminary results from the tazarotene versus adapalene trial suggest that, when tazarotene is applied only half as frequently as adapalene (every other day versus every day), the two drugs achieve comparable reductions in noninflammatory and inflammatory lesion counts. The results from these studies, and a separate split-face tolerability study, suggest that the tolerability of tazarotene gel is clinically comparable to that of tretinoin 0.025% gel, tretinoin 0.1% gel microsphere, and adapalene 0.1% gel. (J Am Acad Dermatol 2000;43:S51-4.)

Dermatoses from artificial limbs

The efficacy and tolerability of tazarotene 0.1% gel in the treatment of acne vulgaris have been compared with those of tretinoin 0.025% gel and adapalene 0.1% gel in multicenter, double-blind, randomized, parallel-group trials. Preliminary results from the tazarotene versus tretinoin trial suggest that once-daily tazarotene is more efficacious than once-daily tretinoin in reducing the numbers of papules and open comedones, and achieves a more rapid reduction in pustules. Both drugs appear to be equally efficacious against closed comedones. Preliminary results from the tazarotene versus adapalene trial suggest that, when tazarotene is applied only half as frequently as adapalene (every other day versus every day), the two drugs achieve comparable reductions in noninflammatory and inflammatory lesion counts. The results from these studies, and a separate split-face tolerability study, suggest that the tolerability of tazarotene gel is clinically comparable to that of tretinoin 0.025% gel, tretinoin 0.1% gel microsphere, and adapalene 0.1% gel. (J Am Acad Dermatol 2000;43:S51-4.)

Adapalene 0.1% gel has low skin irritation potential even when applied immediately after washing

The efficacy and tolerability of tazarotene 0.1% gel in the treatment of acne vulgaris have been compared with those of tretinoin 0.025% gel and adapalene 0.1% gel in multicenter, double-blind, randomized, parallel-group trials. Preliminary results from the tazarotene versus tretinoin trial suggest that once-daily tazarotene is more efficacious than once-daily tretinoin in reducing the numbers of papules and open comedones, and achieves a more rapid reduction in pustules. Both drugs appear to be equally efficacious against closed comedones. Preliminary results from the tazarotene versus adapalene trial suggest that, when tazarotene is applied only half as frequently as adapalene (every other day versus every day), the two drugs achieve comparable reductions in noninflammatory and inflammatory lesion counts. The results from these studies, and a separate split-face tolerability study, suggest that the tolerability of tazarotene gel is clinically comparable to that of tretinoin 0.025% gel, tretinoin 0.1% gel microsphere, and adapalene 0.1% gel. (J Am Acad Dermatol 2000;43:S51-4.)

Efficacy and safety comparison of adapalene (CD271) gel and tretinoin gel in the topical treatment of acne vulgaris. A European multicentre trial

BACKGROUND: Adapalene is a new chemical entity which binds with high affinity to specific nuclear retinoic acid receptors and exhibits tretinoin-like activities in the terminal differentiation process. OBJECTIVE: The purpose of the trial was to compare adapalene 0.1% gel (Differin Gel, Galderma Laboratories) with tretinoin 0.025% gel (Retin A Gel, Cilag Laboratories) in the treatment of acne patients, methods: A multicentre, investigator-masked, parallel-group study included 268 male and female patients with mild to moderate facial acne vulgaris. Treatments were applied once daily for 12 consecutive weeks. RESULTS A total of 134 patients (74 males and 60 females, mean age 19.7 years) received adapalene gel and 134 patients (69 males and 65 females, mean age 19.2 years) tretinoin gel. Among these patients, 259 were evaluable for efficacy and safety and 236 completed the study. The inflammatory, noninflammatory and total lesion counts, and the global facial acne grade were not significantly different between the two treatment groups after 12 weeks of treatment, but the onset of action of adapalene gel appeared to be slightly but not significantly more rapid in reducing inflammatory and total lesion counts at weeks 2 and 4. Some skin irritation was observed with both products, reaching a maximal intensity during week 2 of treatment. Significantly lower mean scores were obtained with adapalene gel than with tretinoin gel for burning (from weeks 2 to 12) dryness and scaling (at weeks 8 and 12). conclusions: Adapalene 0.1% gel was as effective as tretinoin 0.025% gel in a 12-week once-daily treatment of mild to moderate acne vulgaris. Adapalene gel was safe, with low systemic exposure, no detectable systemic toxicity and a significantly better skin tolerability than tretinoin gel.