Facial Lesion Counts Research Articles

Prospective Evaluation of a Topical Botanical Skin Care Regimen on Mild to Moderate Facial and Truncal Acne and Mood

Acne vulgaris is a common inflammatory condition that can be associated with profound psychosocial impacts. Conventional treatment includes topical retinoids, benzoyl peroxide, and antimicrobials, and some may cause irritation and skin dryness. In this 8-week open-label study, we examined the effects of a botanical skin care regimen (Codex Labs Shaant Balancing regimen) on mild to moderate facial and truncal acne. Twenty-four male and female subjects between the ages of 12 and 45 years were assessed for eligibility, 20 were enrolled, and 15 completed all study visits. Facial and truncal acne lesion counts, skin hydration, sebum excretion rate, and mood were assessed at baseline, week 4, and week 8. Total facial lesion counts (inflammatory and non-inflammatory lesions) decreased by 20.5% at week 4 (p = 0.06) and by 25.2% at week 8 (p < 0.05). Inflammatory lesion counts on the trunk were found to decrease at week 8 relative to baseline by 48% (p < 0.05). Forehead sebum excretion rate decreased by 40% at week 4 (p = 0.07) and 22% at week 8 (p = 0.08), and cheek skin hydration increased by 27.6% at week 4 (p = 0.14) and 65% at week 8 (p = 0.10). Participants also experienced significant improvement in components of a positive effect, such as feeling "strong" and "inspired", and a decrease in negative effects, such as feeling "irritable." Overall, the botanical skin care regimen was found to be well-tolerated. Our study suggests that a botanical skin care regimen may reduce facial and truncal acne lesion counts, increase skin hydration, reduce sebum production, and augment positive effects and moods in those with mild to moderate facial and truncal acne.

Clinical behavior of a cohort of adult women with facial acne treated with combined oral contraceptive: ethinylestradiol 20 µg/dienogest 2 mg.

Acne vulgaris is the most common skin disease. It affects the young adult female population and generates great impact on physical and mental health. One of the treatments with good results for affected women is combined oral contraceptive pills (COCPs). The aim of this study was to determine the clinical effect of facial acne management with ethinylestradiol 20 µg/dienogest 2 mg in a cohort of Colombian adult women. A cohort of 120 female university students was followed for 12 months. These participants were enrolled in the Sexual and Reproductive Health Program of the Santiago de Cali University. This cohort admitted women between 18 and 30 years old who had chosen to start birth control with ethinylestradiol 20 µg/dienogest 2 mg COCPs, did not have contraindi cations to the use of COCPs, and had been diagnosed with acne. Monthly monitoring of facial acne lesion count was performed. Relative changes in facial lesion count were identified. At the end of follow-up, the percentage of reduction of lesions was 94% and 23% of women had a 100% reduction in acne lesions. In conclusion, the continued use of the ethinylestradiol 20 µg/dienogest 2 mg COCPs reduced inflammatory and non-inflammatory acne lesions in reproductive-age women between 18 and 30 years of age with no severe acne.

A randomized, double-blind, placebo-controlled study of a novel pantothenic Acid-based dietary supplement in subjects with mild to moderate facial acne.

IntroductionThe purpose of this study was to determine the safety, tolerability and effectiveness of daily administration of an orally administered pantothenic acid-based dietary supplement in men and women with facial acne lesions.MethodsA randomized, double-blind, placebo-controlled study of adults previously diagnosed with mild to moderate acne vulgaris was performed. Subjects were randomized to the study agent, a pantothenic acid-based dietary supplement, or a placebo for 12 weeks (endpoint). The primary outcome of the study was the difference in total lesion count between the study agent group versus the placebo group from baseline to endpoint. Secondary measurements included differences in mean non-inflammatory and inflammatory lesions, Investigators Global Assessment and Dermatology Life Quality Index (DLQI) scores between the two groups. Investigator assessment of overall improvement and skin photographs were also taken. Safety and tolerability endpoints were the assessment of adverse events and measurement of serum complete blood count and hepatic function.ResultsForty-eight subjects were enrolled and 41 were evaluable. There was a significant mean reduction in total lesion count in the pantothenic acid group versus placebo at week 12 (P = 0.0197). Mean reduction in inflammatory lesions was also significantly reduced and DLQI scores were significantly lower at week 12 in the pantothenic acid group versus placebo. The study agent was safe and well tolerated.ConclusionsThe results from this study indicate that the administration of a pantothenic acid-based dietary supplement in healthy adults with facial acne lesions is safe, well tolerated and reduced total facial lesion count versus placebo after 12 weeks of administration. Secondary analysis shows that the study agent significantly reduced area-specific and inflammatory blemishes. Further randomized, placebo-controlled trials are warranted.Electronic supplementary materialThe online version of this article (doi:10.1007/s13555-014-0052-3) contains supplementary material, which is available to authorized users.

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.

Tretinoin Microsphere Gel 0.04% Pump for Treating Acne Vulgaris in Preadolescents: A Randomized, Controlled Study

Although acne vulgaris is common in preadolescents (<13 yrs), few acne treatments are currently approved for children. This study assessed the safety and efficacy of tretinoin microsphere gel (TMG) 0.04% pump in children aged 9-11 with acne vulgaris. In this multicenter, randomized, double-blind, vehicle-controlled pilot study, patients applied TMG 0.04% pump or vehicle once daily to the face for 12 weeks. Efficacy measures were changes in facial lesion counts, Investigator Global Evaluation of acne severity using two scales, and Investigator Global Assessment of Improvement from baseline to week 12. Of the 110 patients enrolled, 55 received TMG 0.04% pump, and 55 received vehicle. At week 12, there was significantly greater improvement in the least-squares mean change in noninflammatory lesions with TMG 0.04% than with vehicle (-19.9 vs -9.7, p = 0.04) and a significant difference in Investigator Global Assessment of improvement at week 12 between the children treated with TMG 0.04% pump and those treated with vehicle (p = 0.02), but there were no discernible differences in static acne severity scales. Change from baseline in signs and symptoms of cutaneous irritation were similar between the active and vehicle arms at week 12. This study demonstrated statistically significant differences in the reduction of noninflammatory lesions between TMG 0.04% pump and vehicle in patients aged 9-11 with acne vulgaris. Additional studies are warranted to further characterize the safety and efficacy of TMG 0.04% pump for the treatment of acne in the preadolescent population.

Cochrane Review: Combined oral contraceptive pills for treatment of acne

AbstractBackgroundAcne 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.ObjectivesTo determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies.Search strategyWe 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). We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed.Selection criteriaAll 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 were eligible.Data collection and analysisWe extracted data on total and specific (i.e., open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan.Main resultsThe search yielded 25 trials: 7 placebo‐controlled trials made 4 different comparisons, 17 trials made 13 comparisons between 2 different COC regimens, and 1 additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self‐assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel, although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found the COC groups were similar.Authors' conclusionsThe four COCs evaluated in placebo‐controlled trials are effective in reducing inflammatory and non‐inflammatory facial acne lesions. Few important differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question.Plain Language SummaryEffect of birth control pills on acne in womenAcne is a common skin problem for women. Several treatments are available. Combined birth control pills, which have the hormones estrogen and progestin, are often prescribed for women with acne. This review looked at how well birth control pills worked to treat facial acne.We did a computer search for studies of birth control pills and acne treatment. Outcomes could be the amount of acne, how severe the acne was, and how many women dropped out early due to problems. We wrote to researchers to find other trials. We included randomized trials in any language that compared two types of birth control pills, a pill and a placebo or 'dummy,' or a pill and another acne treatment.We found 25 trials: 7 trials used 'dummies,' 17 compared different types of birth control pills, and 1 compared a pill and an antibiotic. The three pills studied in trials with dummies worked well to reduce facial acne. In comparing pills with different hormones, no important differences were seen.The conclusions did not change when we added trials in this update to the other studies. Most trials compared two types of pills for acne treatment. Better quality studies are needed to compare one birth control pill with another. How birth control pills compare to other acne treatments like antibiotics is unclear. Since birth control pills improve acne, they can be used to treat women with acne who also want birth control.

Efficacy and safety of Oral Azithromycin in the Treatment of Mild to Moderate Acne Vulgaris

Abstract Background: Acne is a very common skin disorder in our society. Azithromycin, an oral macrolide, has been found to be a new treatment for this disease. Objective: To assess the efficacy and safety of alter-nate day oral azithromycin 500 mg in the treatment of mild to moderate acne vulgaris. Design: A quasi - experimental study. Place and Duration of Study: The study was con-ducted at the Department of Dermatology, Unit - I, KEMU / Mayo Hospital, Lahore, during the six mon-ths period from 11 th April to 10 th October, 2009. Subjects and Methods: One hundred and twenty patients of acne vulgaris were enrolled and baseline lesions were recorded. All patients were advised to take azithromycin 500 mg thrice a week orally for a period of 8 weeks after which they were followed up for the next 8 weeks at 2 weeks interval. The mean facial lesion count at baseline and after 8 weeks thera-py was performed in all the cases. The treatment was considered excellent if there was clearance of >80% of lesions, good at 50 - 80% clearance and poor if there was clearance of < 50% of lesions. The safety of treat-ment administered was assessed on the basis of local or systemic side effects of the drug. Results: Out of 120 evaluable patients, there were 53 males and 67 females. Mean age of the patients was 21.2 ± 4.1 years. The mean facial lesion count after 8 weeks therapy was much reduced. The treatment reve-aled an excellent response in 79 (66%) patients, good in 31 (26%) and poor in 10 (8%) cases. Azithromycin was well tolerated by all the patients. Conclusion: Azithromycin 500mg thrice weekly for 8 weeks is found to be an effective and safe treatment for acne vulgaris. Key Words: Acne, vulgaris, azithromycin, macrolide.

A prospective randomized trial of topical pimecrolimus for cetuximab-associated acne-like eruption

Clinical trials addressing the acneiform rash associated with epidermal growth factor receptor inhibitors are lacking. We evaluated the ability of topical pimecrolimus to reduce the severity of cetuximab-related facial rash. In all, 24 patients with metastatic colorectal cancer with cetuximab facial rash received twice daily pimecrolimus application for 5 weeks to half of the face. At baseline, week 2, and week 5, a dermatologist performed facial lesion counts, patients reported perceived severity of rash-related symptoms, and standardized facial photographs were obtained for blinded evaluation of global rash severity. Treatment sides had greater decrease in lesion counts than observation sides of face at weeks 2 (P < .001) and 5 (P = .02). However, there were no significant differences in patients' assessment of symptoms and in review of facial photographs for rash severity between treatment and observation sides. This study was not placebo controlled. Pimecrolimus application did not translate into clinically meaningful benefit for patients with cetuximab-related facial rash.

Minocycline decreases severity of cetuximab rash

Prophylactic treatment with oral minocycline decreases the severity of cetuximab-related rash, but the benefi cial eff ects are short-lived (J Clin Oncol 2007; 25: 5390–96). Cetuximab is an epidermal growth factor (EGFR) inhibitor that is used to treat metastatic colorectal cancer. However, cetuximab produces an acnelike rash in over 80% of patients treated. Although unpleasant, the appearance of this rash shows a response to the anti-EGFR treatment. Evidence to support an eff ective treatment for rashes linked to EGFR inhibitors has been absent; control of severe cetuximab-related eruptions has been by interrupting treatment or reducing the dose. Alon Scope (Memorial SloanKetter ing Cancer Center, NY, USA) and colleagues randomly assigned 48 patients about to start cetuximab to receive oral minocycline (100 mg daily) or placebo for 8 weeks. Patients were also randomly assigned to receive topical tazarotene treatment to either the right or left side of the face. Total facial lesion counts were lower in patients receiving minocycline between weeks 1 and 4, and at week 4, fewer patients in the minocycline group reported moderate-to-severe itch (20% vs 50%, p=0·05). By week 8, the diff erences between the two groups had diminished. Tazarotene treatment produced no clinical benefi t. The researchers conclude that prophylactic minocycline treatment at the initiation of cetuximab is reasonable, but that beyond 8 weeks, the strategy is not benefi cial. Importantly, suppression of the rash in this manner does not seem to aff ect response to cetuximab. Siegfried Segaert (University Hospital Sint-Rafael, Leuven, Belgium) suggests that prophylactic treatment should now be compared with a reactive regimen, whereby only patients developing severe rash are given the systemic tetracycline. “Then you don’t give oral tetracyclines in an unnecessary way to patients with only mild rash, and you don’t lose rash severity as a pharmacodynamic marker.”

Randomized Double-Blind Trial of Prophylactic Oral Minocycline and Topical Tazarotene for Cetuximab-Associated Acne-Like Eruption

To evaluate the ability of either oral minocycline, topical tazarotene or both, to reduce or prevent cetuximab-related acneiform rash when administered starting on day 1 of cetuximab therapy. Metastatic colorectal cancer patients preparing to initiate cetuximab were randomly assigned to receive daily oral minocycline or placebo, and to receive topical tazarotene application to either left or right side of the face. Both therapies were administered for 8 weeks. Forty-eight eligible patients were randomly assigned to minocycline (n = 24) or placebo (n = 24). Total facial lesion counts were significantly lower in patients receiving minocycline at weeks 1 through 4. At week 4, a lower proportion of patients in the minocycline arm reported moderate to severe itch than in the placebo arm (20% v 50%, P = .05). Facial photographs, obtained at week 4, were reviewed for rash global severity. Patients in the minocycline arm trended toward lower frequency of moderate to severe rash than patients receiving placebo (20% v 42%, P = .13). The differences in total facial lesion counts and subjectively assessed itch were diminished by week 8. Cetuximab treatment was interrupted because of grade 3 skin rash in four patients in the placebo arm, and none in the minocycline arm. There was no observed clinical benefit to tazarotene application. Tazarotene treatment was associated with significant irritation, causing its discontinuation in one third of patients. Prophylaxis with oral minocycline may be useful in decreasing the severity of the acneiform rash during the first month of cetuximab treatment. Topical tazarotene is not recommended for management of cetuximab-related rash.

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 COCs for the treatment of facial acne compared to placebo or other active therapies. We searched the computerized databases Cochrane Skin Group trial register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, Biological Abstracts and LILACS for randomized controlled trials of COCs and acne. We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed. All randomized controlled trials reported in any language that compare the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women were eligible. We extracted data on total and specific (i.e. open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan 4.2. The search yielded five placebo-controlled trials that made three different comparisons and 14 trials that made nine comparisons between two COC regimens. An additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogrestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found no difference between the COCs. The three COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few differences were found in acne effectiveness between COC types. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question.