Noninflammatory Lesion Counts Research Articles

Efficacy and safety of topical nadifloxacin and benzoyl peroxide versus clindamycin and benzoyl peroxide in acne vulgaris: A randomized controlled trial

Background:Topical therapy with comedolytics and antibiotics are often advocated for mild and moderate severity acne vulgaris. Nadifloxacin, a new fluoroquinolone with anti-Propionibacterium acnes activity and additional anti-inflammatory activity, is approved for use in acne. This randomized controlled assessor blind trial compared the clinical effectiveness and safety of eight weeks therapy of nadifloxacin 1% versus clindamycin 1% as add-on therapy to benzoyl peroxide (2.5%) in mild to moderate grade acne.Materials and Methods:The efficacy parameters were changes in the total, inflammatory and non-inflammatory lesion counts, Investigator Global Assessment (IGA), and Cardiff Acne Disability Index (CADI) scales from baseline to study end (eight weeks). All treatment emergent dermatological adverse events were evaluated for safety assessment.Results:Out of 84 randomized subjects (43-nadifloxacin arm) and (41-clindamycin) 42 in nadifloxacin group, 37 in clindamycin group completed the study. Reduction from baseline of total, inflammatory and non-inflammatory lesion counts were highly significant in both the groups (P<0.0001), but between group differences were not significant. Significant improvement in CADI and IGA scales were noted in both groups. Between-group comparison showed no significant differences. The safety and tolerability profile of both regimens were good and statistically comparable.Conclusions:Topical nadifloxacin, a new fluoroquinolone is effective, tolerable, and safe for mild o moderate facial acne. Its clinical effectiveness is comparable to clindamycin when used as add-on therapy to benzoyl peroxide.

A study of the efficacy of cleansers for acne vulgaris

Background: Acne treatments are sometimes expensive, and mild acne patients need some simpler form of treatment and, thus, the need for easier and cheaper ways of managing acne is increasing.Methods: An 8-week, double-blind, randomized clinical trial was conducted to determine whether cleansers are effective at producing clinical improvements in patients with acne vulgaris. A total of 13 acne patients applied cleanser A to one half of the face and cleanser B (cleanser A plus triclosan, salicylic acid, and azelaic acid) to the other half, twice daily.Results: The numbers of inflammatory and non-inflammatory lesions decreased on both sides. A rebound tendency was noted for cleanser A with respect to inflammatory lesions at 4 weeks post-discontinuation, whereas inflammatory lesions continued to decrease on sides treated with cleanser B during this period. However, non-inflammatory lesion counts were not significantly different in the two groups. Though patients were generally satisfied with both treatments, they were more satisfied with cleanser B. Moreover, histopathologic examinations showed a profound decrease in inflammatory reactions in the cleanser B group.Conclusion: These results show that acne cleansers reduced both inflammatory and non-inflammatory acne lesion counts, and might be helpful for acne treatment.

Photodynamic therapy for acne vulgaris: a randomized, controlled, split‐face clinical trial of topical aminolevulinic acid and pulsed dye laser therapy

There remains the need for more effective therapeutic options to treat acne vulgaris. Interest in light-based acne treatments has increased, but few randomized, controlled clinical trials assessing the value of photodynamic therapy (PDT) for acne have been reported. We sought to examine the efficacy of PDT using 5-aminolevulinic acid (ALA) and pulsed dye laser therapy in the treatment of acne. We conducted a randomized, controlled, split-face, single-blind clinical trial of 44 patients with facial acne. Patients were randomized to receive three pulsed dye laser treatments to one side of the face after a 60-90 min ALA application time, while the contralateral side remained untreated and served as a control. Serial blinded lesion counts and global acne severity ratings were performed. Global acne severity ratings improved bilaterally with the improvement noted to be statistically significantly greater in treated skin than in untreated skin. Erythematous macules (remnants of previously active inflammatory lesions) decreased in number in treated skin when compared with control skin and there was a transient but significant decrease in inflammatory papules in treated skin when compared with untreated skin. There were no other statistically significant differences between treated and untreated sides of the face in terms of counts of any subtype of acne lesion. Thirty percent of patients were deemed responders to this treatment with respect to improvement in their inflammatory lesion counts, while only 7% of patients responded in terms of noninflammatory lesion counts. PDT with the treatment regimen employed here may be beneficial for a subgroup of patients with inflammatory acne.

Efficacy, safety, and tolerability of microsphere adapalene vs. conventional adapalene for acne vulgaris

The present study was undertaken to compare the efficacy, safety and tolerability of a new microsphere adapalene formulation and conventional adapalene in adult patients with mild to moderate acne vulgaris. This prospective, randomized, assessor-blind, multi-centric (3 centres) comparative, post-marketing phase IV study was undertaken in 175 patients with mild to moderate acne after approval by respective Institutional review boards. Patients fulfilling selection criteria were randomly assigned to either microsphere adapalene gel or conventional adapalene gel both once daily in the evening for 12 weeks after obtaining their informed consent. Efficacy variables included success rate and percent lesion reduction from baseline. Safety and tolerability was assessed on the basis of physical examination and monitoring of treatment-emergent adverse events. Of the 175 patients (88 in microsphere and 87 in conventional) 21 were lost to follow-up and considered drop-outs. There was a significant decrease (P < 0.05) in mean inflammatory and non-inflammatory lesion and total lesion counts from 1st week onwards in both groups. A significantly lower number of microsphere treated patients (50%) reported a side effect (P < 0.05) as compared to 71.3% in conventional users. A highly significant decrease was observed in dryness and erythema (P < 0.01) in microsphere group compared to conventional. Eight patients in conventional group discontinued therapy due to severe irritation as compared to none in microsphere adapalene group. Therapy with microsphere adapalene provided a better tolerability with minimal irritation compared to conventional adapalene, without compromising efficacy and could be a better therapeutic option for acne.

Comparison of a 3-step acne system containing solubilized benzoyl peroxide versus benzoyl peroxide/clindamycin: A multicenter, investigator-blind, randomized study

CONCLUSIONS The 3-step acne system is an effective antibiotic-free approach to the treatment of acne. Compared with a combination BPO/clindamycin product, the acne system is at least as effective in reducing the noninflammatory lesion count and may enhance the speed at which these lesions are reduced. The acne system also demonstrates comparable efficacy against inflammatory lesions and comparable tolerability. Its potential for a more rapid onset of action against non-inflammatory lesions is likely attributable to the improved solubilization of BPO enhancing the bioavailability and intrafollicular penetration of the BPO. The unique solvent technology employed in the BPO formulation might also play a role in enhancing efficacy in the early weeks of treatment.

Prospective, open‐label, comparative study of clindamycin 1%/benzoyl peroxide 5% gel with adapalene 0.1% gel in Asian acne patients: efficacy and tolerability

Used as individual agents, topical antibiotics and benzoyl peroxide are known to be effective in treatment of acne. Clindamycin phosphate 1% with benzoyl peroxide 5% (CDP/BPO) is a new combination gel, made by rationale, in that combination drug is more effective than either ingredients used alone. Adapalene 0.1% (ADA) is the third-generation retinoid, shown to be as effective as other topical retinoid with well tolerability. To compare the efficacy and tolerability in combination of CDP/BPO in comparison with ADA in Asian patients with mild to moderate acne vulgaris. Total of 69 patients, including 31 patients for CDP/BPO group and 38 for ADA group, with mild to moderate acne vulgaris were enrolled for a 12-week prospective, randomized, open-label comparative study of topical agents. Efficacy was assessed by lesion counts, acne grading system, and global improvement. Adverse events were also evaluated in scale of 0 (none) to 3 (severe). Both CDP/BPO and ADA were effective in reducing lesion counts and acne severity scale and showed significant global improvement. However, CDP/BPO offered greater efficacy against inflammatory lesions than ADA. Both drugs were well tolerated with minimal adverse drug reactions. Combination formulation of CDP/BPO and ADA were shown to be both effective in decreasing total, inflammatory, and non-inflammatory lesion counts along with well tolerability in Asian patients with mild to moderate acne vulgaris.

A study to determine the effect of combination blue (415 nm) and near-infrared (830 nm) light-emitting diode (LED) therapy for moderate acne vulgaris

Background and objective: Acne vulgaris remains a major problem in dermatological practice. Phototherapy for acne with blue (415 nm) and red (633 nm) light-emitting diode (LED) arrays has recently attracted attention. This pilot study assessed the efficacy of the combination of 415 nm and near-infrared (IR) LED therapy for moderate acne. Methods: Seventeen individuals were recruited: 13 females and four males. Skin types ranged from type II to type VI, and the acne grades at baseline ranged from Burton grade 1 to 5. Patients underwent twice-weekly 20-minute sessions of LED therapy for 4 weeks, alternating between the blue (415 nm) and near-IR (830 nm) heads. No other treatment was allowed. Results were assessed and compared with the baseline values at 1, 4 and 8 weeks post-treatment. Results: Six individuals failed to complete the study. Eleven individuals showed improvement ranging from 0% to 83.3%. A downward shift in the Burton grade was seen overall. Non-inflammatory lesion counts increased in four patients, but improved in the other seven by an average of 48.8%. No adverse effects were reported. Conclusions: The combination therapy for acne produced results which were less effective in the reduction of inflammatory lesions than those achieved with the previously reported blue/red combination. Further study with a much larger patient population is warranted.

An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: Assessment of efficacy and safety in 2813 patients

We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris. A total of 2813 patients, aged 12 years or older, were randomized to receive clindamycin-BPO 2.5%, individual active ingredients, or vehicle in two identical, double-blind, controlled 12-week, 4-arm studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts) using Evaluator Global Severity Score and subject self-assessment. Clindamycin-BPO 2.5% demonstrated statistical superiority to individual active ingredients and vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Visibly greater improvement was observed by patients with clindamycin-BPO 2.5% as early as week 2. No substantive differences were seen in cutaneous tolerability among treatment groups and less than 1% of patients discontinued treatment because of adverse events. Data from controlled studies may differ from clinical practice. Clindamycin-BPO 2.5% provides statistically significant greater efficacy than individual active ingredients and vehicle with a highly favorable safety and tolerability profile.

An assessment of the efficacy of blue light phototherapy in the treatment of acne vulgaris

Acne vulgaris is a common skin condition that affects 8 out of 10 people. It varies from mild to severe, and different treatments target various aspects of the disease. Propionibacterium acnes, one of the culprits involved in the pathogenesis of acne vulgaris, is the main target of all major medical treatments used. Studies conducted in recent years have shown favorable effects within the visible light spectrum for the treatment of acne vulgaris. In this study, we have evaluated the use of intense blue light within the spectral range of 415-425 nm (peak 420 nm) in the treatment of acne vulgaris. Twenty-one patients with mild to moderate facial acne were treated with blue light phototherapy. All patients were given 14-min treatment sessions twice a week for 4 weeks. Acne severity was assessed using the Leeds Technique for grading and lesion counts. Disability was assessed using the Dermatology Life Quality Index (DLQI). In addition, standard digital and cross-polarized light photographs were taken and graded by a blinded evaluator. Visual analog scale (VAS) scores and cultures for P. acnes were carried out before starting the treatment and upon completion of the treatment. Significant improvement was achieved in the Leeds Acne Grade (P = 0.001). The inflammatory (P = 0.001) and noninflammatory (P = 0.06) lesion counts also improved significantly. A similar change was noted in the DLQI (P = 0.001); a degree of significance was also achieved in the patients' and the investigators' VAS scores (P = 0.01 and P = 0.001, respectively). P. acnes colony counts failed to show a significant decrease at the end of the treatment and remained almost constant (P = 0.660). We believe that blue light does appear to have some role in the management of acne and may be beneficial for the treatment of a select group of mild to moderate acne patients.

Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled trial

Background A randomized, double-blind, parallel-group study to investigate the efficacy and safety of the 3 mg drospirenone (drsp)/20 mcg ethinylestradiol (EE) combined oral contraceptive (COC) administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle) for the treatment of moderate acne vulgaris. Study Design Healthy females (aged 14–45 years old) with moderate facial acne were randomized to 3 mg drsp/20 mcg ( n=266) or placebo ( n=268) for six cycles of 28 days. Results Women who received the 3 mg drsp/20 mcg EE 24/4 COC had greater reductions from baseline in inflammatory, noninflammatory and total lesion counts. The odds of women in the 3 mg drsp/20 mcg EE 24/4 regimen COC group having ‘clear’ or ‘almost clear’ skin as rated by the investigators at end point was about fourfold greater than that in the placebo group (odds ratio 4.31; 95% CI: 2.11–9.60; p=.001). The 3 mg drsp/20 mcg EE 24/4 regimen COC was well tolerated and had a safety profile consistent with low-dose COC use. Conclusion The 3 mg drsp/20 mcg EE 24/4 regimen COC was significantly more effective than placebo in treating moderate acne vulgaris.

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.

Red Light Phototherapy Alone Is Effective for Acne Vulgaris

BACKGROUND Recently, a demand for safe and effective treatment of acne has been increasing. Although visible light has attracted attention as a new option, the effect of red light alone has not yet been evaluated. OBJECTIVES The objective was to assess the efficacy of red light phototherapy with a portable device in acne vulgaris. METHODS Twenty-eight volunteers with mild to moderate acne were treated with portable red light–emitting devices in this split-face randomized trial. The right or left side of the face was randomized to treatment side and phototherapy was performed for 15 minutes twice a day for 8 weeks. Clinical photographs, lesion counts, and a visual analog scale (VAS) were used to assess each side of the face at baseline and Weeks 1, 2, 4, and 8, and a split-face comparison was performed. RESULTS The percent improvement in noninflammatory and inflammatory lesion counts of the treated side was significant compared to the control side (p<.005). VAS decreased from 3.9 to 1.9 on the treatment side and the difference between the treatment and control sides was significant at Week 8 (p<.005). CONCLUSIONS This study shows that red light phototherapy alone can be a new therapeutic option for acne vulgaris.

Double-blind, randomized, placebo-controlled study of a lotion containing triethyl citrate and ethyl linoleate in the treatment of acne vulgaris

Acne vulgaris is a major clinical problem; despite a vast array of treatment modalities available for acne, there is considerable dissatisfaction in acne treatment among patients and doctors. Rising antibiotic drug resistance consequent to the widespread use of topical antibiotics is causing concern and effective nonantibiotic treatments are needed. To evaluate the efficacy and tolerability of a novel lotion containing triethyl citrate and ethyl linoleate in the treatment of mild to moderate acne vulgaris. This was a double-blind, placebo-controlled, randomized study comparing the active lotion containing triethyl citrate and ethyl linoleate with its vehicle as a placebo control. Patients were assessed by the modified Leeds acne grading system as well as by counting inflammatory and noninflammatory lesions on the face at weeks 0, 4, 8 and 12. Sebum production was assessed by the Sebutape method at weeks 0 and 12. All adverse events were recorded. Forty patients were recruited into the study, of whom 33 completed the study. Active treatment was statistically superior to placebo in reduction of Leeds grading and total, inflammatory and noninflammatory lesion counts. The active lotion showed a rapid response with obvious reduction in lesion counts and acne grading by 4 weeks. Sebum production was significantly reduced in the actively treated group, with a mean reduction of 53% in sebum production compared with baseline. One patient developed irritation to the active lotion and withdrew from the study. The new lotion containing triethyl citrate and ethyl linoleate has been shown to be an effective treatment for mild to moderate acne, with an effect on both inflammatory and noninflammatory acne lesions. The new lotion worked quickly and was generally well tolerated. A surprising finding was the significant impact the new lotion has on sebum production, suggesting a role in patients with seborrhoea. This nonantibiotic preparation will be a very useful addition to existing treatments for acne.

Red Light Phototherapy Alone Is Effective for Acne Vulgaris: Randomized, Single-Blinded Clinical Trial

Recently, a demand for safe and effective treatment of acne has been increasing. Although visible light has attracted attention as a new option, the effect of red light alone has not yet been evaluated. The objective was to assess the efficacy of red light phototherapy with a portable device in acne vulgaris. Twenty-eight volunteers with mild to moderate acne were treated with portable red light-emitting devices in this split-face randomized trial. The right or left side of the face was randomized to treatment side and phototherapy was performed for 15 minutes twice a day for 8 weeks. Clinical photographs, lesion counts, and a visual analog scale (VAS) were used to assess each side of the face at baseline and Weeks 1, 2, 4, and 8, and a split-face comparison was performed. The percent improvement in noninflammatory and inflammatory lesion counts of the treated side was significant compared to the control side (p<.005). VAS decreased from 3.9 to 1.9 on the treatment side and the difference between the treatment and control sides was significant at Week 8 (p<.005). This study shows that red light phototherapy alone can be a new therapeutic option for acne vulgaris.

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.

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 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.