Reduction In Inflammatory Lesion Count Research Articles

External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort

Background: Previously, a new dichotomous outcome was developed, calculated as 55% reduction in the International Hidradenitis Suppurativa 4 (IHS4-55) score. It was validated in datasets of adalimumab and placebo-treated HS patients. External validation is an important aspect of clinical outcomes. Objectives: We aimed to externally validate the novel dichotomous IHS4-55 in a non-biologic treated dataset of HS patients. Methods: Data from a previously published European-wide prospective clinical study of antibiotic treatment of HS patients were used to assess the association of IHS4-55 achievement with individual reduction in inflammatory nodules, abscesses, and draining tunnels. Moreover, the associations between IHS4-55 positivity and achievement of the minimal clinically important differences (MCIDs) for Dermatology Life Quality Index (DLQI), Numerical Rating Scale (NRS) Pain, and NRS Pruritus were analyzed. Results: Data were obtained from 283 individual patients, of which 36.4% (103/283) were treated with clindamycin and rifampicin and 63.6% (180/283) with tetracyclines for 12 weeks. Achievers of the IHS4-55 demonstrated a significant reduction the counts of inflammatory nodules, abscesses, and draining tunnels (all p < 0.001). Additionally, IHS4-55 achievers had an odds ratio for achieving the MCID of DLQI, NRS Pain, and NRS Pruritus of 2.16 (95% CI 1.28–3.65, p < 0.01), 1.79 (95% CI 1.10–2.91, p < 0.05), and 1.95 (95% CI 1.18–3.22, p < 0.01), respectively. Conclusions: This study shows the external validity of the novel IHS4-55 by demonstrating a significant association between IHS4-55 achievement and a reduction in inflammatory lesion counts as well as achievement of MCIDs for DLQI, NRS Pain, and NRS Pruritus in an antibiotic-treated cohort. These findings support the use of the IHS4-55 as a novel primary outcome measure in clinical trials.

Selective photothermolysis with a novel 1726 nm laser beam: A safe and effective solution for acne vulgaris

Selective photothermolysis on sebaceous glands is an effective method for treating acne vulgaris (AV); however, safety, efficacy, and discomfort hinder its utilization in clinical settings. The primary objective is to evaluate the safety and efficacy of a novel 1726 nm laser with contact cooling to treat AV. Seventeen patients aged 18 to 36 were enrolled and treated in this IRB-approved, single-center, open-label study. Patients received up to three facial laser sessions up to seven weeks apart. Follow-up visits happened ten days post-session and at the 4 and 12 weeks following the final session. The investigator assessed the severity of device-related adverse events (AEs). Investigator Global Assessment (IGA) and inflammatory lesion counts (ILC) were used as metrics to evaluate acne resolution and skin condition enhancement. Patients' perspectives on satisfaction and comfort using this technology were assessed using Subject Experience Questionnaires (SEQ). Safety assessment showed mild and transient AEs. All subjects tolerated anesthetics-free treatments well, with a mean treatment discomfort score of 4.9± 1.5. Compared to baseline, a statistically significant reduction in ILC (p=0.003) of 52% to 56% is achieved four to twelve weeks following treatment. Long-term follow-ups showed progressive improvement 24 months post-treatment with a 97% reduction in ILC. SEQs revealed high subject satisfaction (71%) with psychosocial improvement three months post-treatment. The novel 1726 nm laser appears safe and effective for treating mild-to-severe acne. Acne resolution is apparent within the first month and progresses beyond the study duration.

Refining how we measure as we test: new insights using adalimumab in patients with hidradenitis suppurativa.

In the SOLACE study, Gulliver et al.1 evaluate the real-world effectiveness of adalimumab, the first, and, to date, only medication approved for treatment of hidradenitis suppurativa (HS), a debilitating condition characterized by recurrent inflammatory nodules, abscesses, and fistulas. In this large open-label cohort of 138 patients treated with adalimumab, 68.9% achieved HiSCR (a 50% reduction in inflammatory lesion counts) at week 24, higher than the results seen in the PIONEER studies at week 12. Patients with medium to high inflammatory lesion counts (abscesses and inflammatory nodules AN) counts experienced the best response. During the pivotal adalimumab clinical trials, primary endpoints were based on the HiSCR,2 a measure that was analytically derived from the convergence of clinical and patient-reported data in an adalimumab trial. HiSCR does not incorporate improvements in fistulae. Since then, additional tools have emerged including the International HS Severity Score System (IHS4)3 which designates higher weights to draining fistulas and abscesses and, therefore, measures something different than HiSCR. As there is an overlap in the measures, it is not surprising that Gulliver et al. demonstrated that HiSCR responders also had a decrease in IHS4 scores. The best IHS4 responders were those with high AN counts, which seem most responsive to adalimumab. This finding is consistent with work by Frew et al.,4 who did not demonstrate a significant change in the IHS4 category when retrospectively applying the IHS4 to the PIONEER 1 data. Fistulas are an extremely important part of HS, and better treatment options as well as ways to measurement the impact of improvement may still emerge. In the meantime, it seems reasonable to use both scores. It is hard to get HS under control. The first studies with adalimumab showed successful treatment required relatively high doses. Taking into account the open-label design and some population differences, this study confirms that a long duration of treatment may be important to achieve desired clinical effect: the proportion of patients who achieved HiSCR increased from 69% at week 24 to 82% and 75% at week 52 for patients.2 It is difficult to maintain placebo groups past a few months in placebo controlled studies. Given the advances in the field, now is the time to move into an era with more head-to-head comparisons, which will also allow the use of longer primary endpoints. In the meantime, the guidance that it takes time to attain desired effects with adalimumab and other treatments is important for patients and physicians. HS is still hard to treat, but we are continuing to improve both our approach and our results. Dr. Kimball is a consultant and investigator for Abbvie, Bristol Meyers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, and UCB, Incyte; consultant for Regeneron and Bayer, receives fellowship funding from Janssen and Abbvie; and is on the Board of Directors of Almirall. None.

Oral Sarecycline for Treatment of Papulopustular Rosacea: Results of a Pilot Study of Effectiveness and Safety.

Cutaneous rosacea is a common inflammatory skin disorder that often presents with facial papulopustular lesions that are frequently bothersome to patients. Studies have shown oral sarecycline to be effective and safe for acne, with a low risk of side effects that are historically associated with other tetracycline-class drugs such as doxycycline and minocycline, in addition to offering a reduced risk of emergence of resistant bacteria due to its narrow-spectrum of antibiotic activity. Oral sarecycline is FDA-approved for the treatment of acne (2018). A pilot study to evaluate the efficacy and safety of oral sarecycline in papulopustular rosacea. A 12-week, prospective, parallel-group, investigator-blinded, controlled pilot study was completed evaluating once-daily sarecycline, using weight-based oral dosing as recommended for acne vs control (multivitamin tablet), for the treatment of moderate-to-severe papulopustular rosacea in adult subjects (n=102), aged ≥18 years. The primary efficacy endpoint was Investigator’s Global score (IGA; clear or almost clear) and percent reduction in inflammatory lesion count at week 12. Safety and tolerability assessments were performed as well. A total of 102 subjects were randomized; 97 completed the study. At week 12, IGA improvement was significantly greater for oral sarecycline when compared to the control (P<0.0001). Furthermore, absolute and percent reductions in inflammatory lesion counts were significantly greater in the sarecycline group for all weeks (4, 8, and 12) when compared to the control (P<0.001). Significant improvement in facial burning, erythema, and pruritus was reported in the sarecycline group, when compared to the control (P<0.05). No serious AEs were reported. Sarecycline was effective, safe, and well-tolerated for treating papulopustular rosacea in adults with marked superiority in efficacy compared to subjects in the control group. With its narrow-spectrum activity, oral sarecycline may be a good option for the treatment of papulopustular rosacea. Additional studies are warranted to confirm the positive results of this pilot study.

Janus kinase inhibitors for atopic dermatitis: a promising treatment modality.

Atopic dermatitis (AD) is chronic, pruritic, inflammatory skin disease that affects a significant portion of the population in industrialized nations. For nonresponders to conventional therapies, AD can significantly reduce sleep quality and quality of life. AD pathogenesis is multifactorial and involves multiple immune pathways, with recent evidence of T helper (Th)2, Th17 and Th22 axis attenuation in various AD endotypes and racial subtypes. Inhibition of the conserved Janus kinase (JAK) signalling pathway represents a promising therapeutic avenue to reduce the activation of multiple proinflammatory mediators involved in AD pathogenesis. JAK inhibitors exist in both oral and topical forms with variable specificity for the receptor tyrosine kinases JAK1, JAK2, JAK3 and tyrosine kinase 2. Oral formulations include abrocitinib, upadacitinib, baricitinib and gusacitinib, and are most appropriate for patients with moderate to severe AD. Emerging topical formulation in development include ruxolitinib and deglocitinib, which may be used in patients with localized AD and also adjunctively with systemic therapy in patients with more severe disease. With observed rapidity in itch relief and accompanying dramatic reduction in inflammatory lesion count, JAK inhibitors represent a promising new treatment to revolutionize the management of AD.

Clinical response rate and flares of hidradenitis suppurativa in the treatment with adalimumab.

Hidradenitis suppurativa/acne inversa (HS) is a chronic, inflammatory, skin disease. adalimumab is the sole approved drug for the treatment of HS, but it only partially controls the symptoms. To evaluate the incidence of flares during 108weeks of therapy and the clinical response to adalimumab. In total, 20 patients with moderate-severe HS treated with adalimumab were included to evaluate the number of flares, mean time interval between flares, lesion count number of patients who reached the Hidradenitis Suppurativa Clinical Response (HiSCR) of ≥50% reduction in inflammatory lesion count, and the International Hidradenitis Suppurativa Severity Score System (IHS4), pain visual analogue scale (VAS) and Dermatology Life Quality Index (DLQI). In total, 90% of patients reported at least 1 flare, and in total 48 flares were counted for the whole group; mean time between flares was 26.9±16.4weeks. Duration between flares was 30.5±16.3 and 12.5±5.7, respectively, in responders and nonresponders. A progressive decline in flares was observed with treatment, while a gradual increase in the number of patients achieving HiSCR was attained during the observational period. Lesion count, IHS4, pain VAS and DLQI decreased throughout the study. In detail, adalimumab showed a higher efficacy on nodules and abscesses than on draining tunnels. The study was limited by its retrospective nature and small number of patients. Adalimumab is an effective and safe treatment for patients with HS despite the high number of flares.

The efficacy, safety, and tolerability of ivermectin compared with current topical treatments for the inflammatory lesions of rosacea: a network meta-analysis.

BackgroundRosacea is a common chronic skin condition that manifests as recurrent inflammatory lesions. Long-term treatment is required to control symptoms and disease progression, with topical treatments being the first-line choice. Ivermectin 1 % cream is a new once-daily (QD) topical treatment for the inflammatory lesions of rosacea, and it is important to compare the efficacy, safety, and tolerability of ivermectin with other currently available topical treatments.MethodsA systematic literature review was performed from January 2011 to June 2015, with articles published prior to 2011 retrieved from a Cochrane review on rosacea. Randomized controlled trials of the topical treatment of adult patients with moderate-to-severe papulopustular rosacea were identified from electronic databases and trial registers, and supplemented with data from clinical study reports. Mixed treatment comparisons (MTCs) were conducted to compare different treatments according to Bayesian methodology.Results57 studies were identified, with 19 providing data suitable for MTC. Ivermectin 1 % cream QD led to a significantly greater likelihood of success compared with azelaic acid 15 % gel twice-daily (BID) [relative risk (95 % credible interval): 1.25 (1.14–1.37)], and metronidazole 0.75 % cream BID [1.17 (1.08–1.29)] at 12 weeks. Ivermectin 1 % cream QD also demonstrated a significant reduction in inflammatory lesion count compared with azelaic acid 15 % gel BID [−8.04 (−12.69 to −3.43)] and metronidazole 0.75 % cream BID [−9.92 (−13.58 to −6.35)] at 12 weeks. Ivermectin 1 % cream QD led to a significantly lower risk of developing any AE or TRAE compared with azelaic acid 15 % gel BID [0.83 (0.71–0.97) and 0.47 (0.32–0.67), respectively].ConclusionsIvermectin 1 % cream QD appears to be a more effective topical treatment than other current options for the inflammatory lesions of rosacea, with at least an equivalent safety and tolerability profile, and could provide physicians and dermatologists with an alternative first-line treatment option.Electronic supplementary materialThe online version of this article (doi:10.1186/s40064-016-2819-8) contains supplementary material, which is available to authorized users.

Multicenter randomized controlled trial on combination therapy with 0.1% adapalene gel and oral antibiotics for acne vulgaris: Comparison of the efficacy of adapalene gel alone and in combination with oral faropenem

We conducted a randomized controlled trial in patients with acne vulgaris with moderate to severe inflammatory lesions. The patients were assigned to the following three treatment groups: group A received monotherapy with 0.1% topical adapalene gel for 4 weeks; group B received combination therapy with 0.1% topical adapalene gel and 600 mg oral faropenem for 2 weeks followed by 0.1% topical adapalene gel alone for 2 weeks; and group C received combination therapy with 0.1% topical adapalene gel and 600 mg oral faropenem for 4 weeks. The result of the analysis indicated that the percentage reduction in inflammatory lesion counts after 2 weeks of treatment was significantly higher in groups B and C than in group A (P < 0.05). After 4 weeks of treatment, group C showed significantly higher percentage reduction in inflammatory lesion counts than in groups A and B (P < 0.05), whereas no significant difference was noted between the latter two groups. Adverse reactions included dryness and irritation at the adapalene application sites that were observed in 10.1% of cases (16/158 patients) and diarrhea and loose stool because of oral faropenem that were observed in 7.5% of cases (8/106 patients). Taken together, our results suggest that combination therapy with oral antibiotics and adapalene results in earlier improvement in patients with moderate to severe inflammatory acne compared to the application of adapalene alone, and that 4 weeks of the combination therapy is preferable to 2 weeks of treatment.

Efficacy and tolerability of oral lactoferrin supplementation in mild to moderate acne vulgaris: an exploratory study

Objective:Lactoferrin, an innate defense iron-binding protein, possesses antimicrobial and anti-inflammatory activities. Beneficial systemic effects on inflammatory diseases have been proposed. The aim of the present study was to explore the efficacy and tolerability of oral bovine lactoferrin supplementation in subjects with mild to moderate facial acne vulgaris.Methods:In this open-label, single-arm study, 43 adolescents and young adults were enrolled to take a chewable tablet formulation of bovine lactoferrin twice daily for 8 weeks. The primary efficacy endpoint was the improvement in acne lesion counts compared with baseline. Tolerability was evaluated on the basis of adverse event frequencies.Results:Thirty-nine subjects, aged 17.5 ± 3.8 years, completed the study per protocol. At the end of the study (week 8), a mean reduction in inflammatory lesion count of 20.2% (−2.2 ± 7.0, p = 0.054), in non-inflammatory lesion count of 23.5% (−6.2 ± 9.8, p < 0.001), and in total lesion count of 22.5% (−8.4 ± 13.1, p < 0.001) was observed as compared with baseline. At study conclusion, 76.9% (30 of 39) of subjects showed a reduction in total lesion count. The results for inflammatory acne lesions were variable over the study course. None of the subjects experienced a lactoferrin-related adverse event during the trial.Conclusion:Despite the limitations of an uncontrolled, open-label study, the results from this study indicate that lactoferrin in mild to moderate acne vulgaris is well tolerated and may lead to an overall improvement in acne lesion counts in the majority of affected adolescents and young adults when administered as a dietary supplement on a twice daily regimen. Further randomized, placebo-controlled trials of longer duration appear warranted.

Efficacy of oral antibiotics on acne vulgaris and their effects on quality of life: A multicenter randomized controlled trial using minocycline, roxithromycin and faropenem

There are few clinical studies which compare the efficacy and patient satisfaction for oral antibiotics to treat inflammatory acne. To clarify the difference between oral antibiotics, acne patients with moderate to severe inflammatory eruptions were randomized into three groups, and each patient was given minocycline (MINO), roxithromycin (RXM) or faropenem (FRPM) for 4 weeks, followed by 4 weeks of observation without any oral antibiotics. We estimated the reduction rate of inflammatory lesion counts, the scale of Skindex-16 which represents patient quality of life (QOL), and minimum inhibitory concentrations required to inhibit the growth of 90% of Propionibacterium acnes isolated from acne patients (MIC(90) ). In all three groups, inflammatory lesion counts, and emotional and total score of Skindex-16 were significantly improved (P<0.05) after 4 weeks treatment, and these effects were maintained for the following 4 weeks. Dizziness/nausea in two patients (4.1%) of the MINO group and diarrhea in three patients (5.9%) of the FRPM group were observed. There was no significant difference of percentage reduction in inflammatory lesion counts and incident rates of side-effects between these three oral antibiotics. MIC(90) of MINO was 0.25 μg/mL before and after treatment, but MIC(90) of RXM had increased from 0.25 μg/mL to more than 32 μg/mL after treatment. MIC(90) of FRPM was 0.06 μg/mL or less for all strains before and after treatment. Our randomized controlled clinical trial suggested that MINO, RXM and FRPM were efficient to improve inflammatory acne and patient QOL, and there was no significant difference between them.

Clindamycin/Benzoyl Peroxide Gel (BenzaClin??)

Clindamycin 1%/benzoyl peroxide 5% (BenzaClin) is a combination gel indicated for use twice daily, or as directed by a physician, for the topical treatment of inflammatory and noninflammatory lesions of acne vulgaris. In well designed clinical trials in patients with mild to moderately severe acne, the efficacy of once- or twice-daily clindamycin/benzoyl peroxide in the reduction of inflammatory lesion counts was greater than that of benzoyl peroxide alone, clindamycin alone, or tretinoin plus clindamycin, and not significantly different from that of erythromycin/benzoyl peroxide. In the reduction of noninflammatory lesion counts, the efficacy of once- or twice-daily clindamycin/benzoyl peroxide was greater than that of clindamycin alone, but not significantly different to that observed with benzoyl peroxide, tretinoin plus clindamycin, or erythromycin/benzoyl peroxide. Clindamycin/benzoyl peroxide has a fairly rapid onset of action, with acne improvement usually recorded within 2-4 weeks. Despite widespread use, bacterial resistance is not associated with clindamycin/benzoyl peroxide. The product is generally well tolerated, and the main treatment-related adverse events in clinical trials were application-site dryness, irritation, peeling, and erythema. Thus, clindamycin/benzoyl peroxide is an effective and well tolerated option for the management of mild to moderately severe acne.

Treatment of Facial Acne Papules and Pustules in Korean Patients Using an Intense Pulsed Light Device Equipped with a 530- to 750-nm Filter

BACKGROUND A rising number of laser- or light-based therapies are addressing the need for effective acne treatments with minimal downtime. OBJECTIVE The purpose of this study is to evaluate an intense pulsed light (IPL) equipped with a 530- to 750-nm filter for inflammatory acne treatment. PATIENTS AND METHODS Thirty female patients (mean age, 25.7 years) with mild-to-moderate acne were enrolled. While using benzoyl peroxide (BP) gel, one side of the face was treated with the PR filter (acne filter) of the IPL. RESULTS All patients experienced the reduction of inflammatory lesion counts in both sides of face. There was no significant difference between IPL-treated and untreated sides of the face for mean papule plus pustule counts, 3 weeks after three sessions. As to red macules, 63% were good or excellent on the laser-treated side compared to 33% on the untreated side. Improvement of irregular pigmentation and skin tone was detected on the laser-treated side than the untreated side. CONCLUSION This new wavelength band of IPL system was safe and effective in improving acne red macules, irregular pigmentation, and skin tone but did not affect inflammatory acne lesion counts on the skin of Asian persons.

Oral R115866 in the treatment of moderate to severe facial acne vulgaris: an exploratory study

R115866 (Rambazole; Barrier Therapeutics NV, Geel, Belgium), a new-generation retinoic acid metabolism-blocking agent, is a nonretinoid compound enhancing intracellularly the endogenous levels of all-trans-retinoic acid by blocking its catabolism. By virtue of this property, and the proven positive effects of retinoids in the treatment of acne, R115866 could potentially be a useful drug for acne. To explore the efficacy, safety and tolerability of systemic R115866 in male patients with moderate to severe facial acne vulgaris (at least 15 papules and/or pustules and at least two nodulocystic lesions). In this exploratory trial, 17 patients were treated with oral R115866 1 mg once daily for 12 weeks, followed by a 4-week treatment-free period. At the end of treatment (week 12, n = 16) a mean reduction in inflammatory lesion count of 77.4% (P < 0.001), in noninflammatory lesion count of 58.3% (P < 0.001) and in total lesion count of 76.0% (P < 0.001) was observed as compared with baseline. All lesion counts were significantly reduced from week 4 onwards. Mild side-effects were reported occasionally. The current data indicate that treatment with oral R115866 1 mg once daily for 12 weeks in patients with moderate to severe facial acne vulgaris is efficacious and well tolerated and merits further investigation.

Treatment of Facial Acne Papules and Pustules in Korean Patients Using an Intense Pulsed Light Device Equipped with a 530- to 750-nm Filter

A rising number of laser- or light-based therapies are addressing the need for effective acne treatments with minimal downtime. The purpose of this study is to evaluate an intense pulsed light (IPL) equipped with a 530- to 750-nm filter for inflammatory acne treatment. Thirty female patients (mean age, 25.7 years) with mild-to-moderate acne were enrolled. While using benzoyl peroxide (BP) gel, one side of the face was treated with the PR filter (acne filter) of the IPL. All patients experienced the reduction of inflammatory lesion counts in both sides of face. There was no significant difference between IPL-treated and untreated sides of the face for mean papule plus pustule counts, 3 weeks after three sessions. As to red macules, 63% were good or excellent on the laser-treated side compared to 33% on the untreated side. Improvement of irregular pigmentation and skin tone was detected on the laser-treated side than the untreated side. This new wavelength band of IPL system was safe and effective in improving acne red macules, irregular pigmentation, and skin tone but did not affect inflammatory acne lesion counts on the skin of Asian persons.

Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea

Doxycycline monotherapy at antimicrobial doses has been shown to be effective for the treatment of rosacea. To evaluate the efficacy and safety of once-daily anti-inflammatory dose doxycycline for the treatment of rosacea. In two phase III, parallel-group, multicenter, randomized, double-blind, placebo-controlled studies (studies 301 and 302), patients received 40-mg of controlled-release doxycycline (n = 269) or placebo (n = 268) for 16 weeks. The primary efficacy end point was the mean change from baseline in facial inflammatory lesion count. The mean lesion count at baseline was approximately 20 in each study arm. At week 16, the mean change from baseline in lesion count in the active-treatment groups was -11.8 in study 301 and -9.5 in study 302 compared with -5.9 and -4.3, respectively, in the placebo groups (P < .001 for both comparisons). Anti-inflammatory dose doxycycline was well tolerated; the most common adverse events were nasopharyngitis (4.8%), diarrhea (4.4%), and headache (4.4%). In both studies, the reduction of inflammatory lesion counts did not plateau within the 16-week time frame in either treatment group. Rosacea is often treated for a period of months or years. The duration of the studies did not allow for assessment of safety beyond 16 weeks or whether the progressive improvement seen with active treatment would continue beyond 16 weeks. Neither study assessed the effect of treatment in patients with only erythematotelangiectatic (subtype 1) rosacea. Once-daily anti-inflammatory dose doxycycline appears to be effective and safe for the treatment of rosacea.

Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris

A new aqueous gel formulation of dapsone has been developed that allows clinically-effective doses of dapsone to be administered topically with minimal systemic absorption. The goal of these studies was to evaluate the efficacy and safety of dapsone gel, 5% in the treatment of acne. Patients 12 years of age and older with acne vulgaris (N = 3010) participated in two identically-designed 12-week, randomized, double-blind studies of twice-daily monotherapy with dapsone gel, 5%, versus a vehicle gel. Dapsone gel-treated patients achieved superior results in terms of the investigator's global acne assessment (P < .001) and the mean percentage reduction in inflammatory, noninflammatory, and total lesion counts (all, P < .001) at week 12. Reductions in inflammatory lesion counts favoring dapsone gel over vehicle were apparent as early as 2 weeks and reached statistical significance by 4 weeks. No clinically significant changes in laboratory parameters, including hemoglobin, even among glucose-6-phosphate dehydrogenase-deficient patients, were observed. Adverse events were comparable between the treatment groups and rarely led to discontinuation. Adjunctive topical treatments and their impact on acne were not studied in this trial. Dapsone gel, 5% appears to be an effective, safe, and well-tolerated treatment for acne vulgaris, with a rapid onset of action.

Tazarotene versus tazarotene plus clindamycin/benzoyl peroxide in the treatment of acne vulgaris: A multicenter, double-blind, randomized, parallel-group trial

Topical retinoids offer highly effective treatment for both inflammatory and non-inflammatory acne, with tazarotene demonstrating greater efficacy than other topical retinoids. A multicenter, double-blind, randomized, parallel-group trial has been performed to evaluate whether the adjunctive use of clindamycin/benzoyl peroxide could enhance the efficacy of tazarotene still further. Patients with moderate to severe inflammatory acne applied tazarotene 0.1% cream each evening and were randomly assigned to morning applications of vehicle gel or a ready-to-dispense formulation of clindamycin 1%/benzoyl peroxide 5 % gel containing 2 emollients. Tazarotene/clindamycin/benzoyl peroxide achieved a significantly greater reduction in comedo count than tazarotene monotherapy and, among patients with a baseline papule plus pustule count of > or =25 (the median value), a significantly greater reduction in inflammatory lesion count. The combination therapy was also at least as well-tolerated as tazarotene monotherapy. The adjunctive use of clindamycin/benzoyl peroxide gel with tazarotene cream promotes greater efficacy and may also enhance tolerability. Any improvements in tolerability could be due to the emollients in the clindamycin/benzoyl peroxide gel formulation.