OBJECTIVE: The objective of this study was to evaluate the psychometric performance of the Acne Symptom and Impact Scale (ASIS) for use in adolescents and adults with acne vulgaris.
METHODS: Psychometric evaluation was performed using both traditional psychometrics in line with proposed US Food and Drug Administration
(FDA) criteria and new psychometric methods, Rasch Measurement Theory (RMT). Assessment of equivalence was also evaluated between Caucasians and Non-Caucasians on individual items.
RESULTS: One-hundred fifty subjects completed baseline and follow-up assessments (89 [59.33%] in the Caucasian group and 61 [40.67%] in the Non-Caucasian group). Psychometric analyses demonstrated that the ASIS Sign and Impact domains both performed
well. Each domain fulfilled traditional psychometric criteria (Cronbach’s alpha=0.79-0.92; test-retest reliability=0.75-0.78) and mostly satisfied Rasch psychometric criteria (person-reliability=0.72-0.93; person-separation=1.61-3.69). Select individual ASIS Items also performed well across all measures and were shown to be reliable and valid as stand-alone items. A similar pattern of results were found for both Caucasian and Non-Caucasian racial subgroups.
CONCLUSIONS: These findings provide empirical evidence that the ASIS is a reliable and valid PRO measure that can accurately assess the severity of symptoms and impacts associated with acne vulgaris.
J Drugs Dermatol. 2015;14(6):552-559.
BACKGROUND: Acne vulgaris is a common inflammatory skin disorder. There remain few rapid, safe, and effective therapy options for patients with moderate to severe acne vulgaris that also address psychological comorbidities such as anxiety.
OBJECTIVE: To assess the efficacy of interleukin 1 alpha blockade in patients with moderate to severe acne vulgaris using the true human monoclonal antibody MABp1.
METHODS: Eleven patients were administered open-label, subcutaneous injections of MABp1 over a six-week period. Objectives were assessment of safety, change in inflammatory lesion count and change in psychosocial functioning using two validated questionnaires.
RESULTS: There were no serious adverse events, or adverse events greater than grade I. Median inflammatory lesion counts decreased 36% (IQR -44% to 1%). Anxiety scores improved (from median 6 to 1) as well as self-image assessment (2.3±0.9 to 2.1±0.1) as measured by the Hospital Anxiety and Depression Scale and the modified Body Image Disturbance Questionnaire.
CONCLUSION: Patients had rapid improvement of skin lesions, as well as psychosocial functioning and anxiety. MABp1 may provide a safe and effective means for treating inflammatory acne lesions and. Further studies using this antibody are warranted in this patient population.
J Drugs Dermatol. 2015;14(6):560-564.
Acne is a very common skin disease; frequently seen in adolescents and often persisting or occurring into adulthood. Topical therapy is very effective in mild to moderate disease, and is used as maintenance therapy. Fixed combination products have been studied in moderately severe disease. Combinations of benzoyl peroxide and either clindamycin or adapalene appear very effective. When utilizing a topical retinoid alone or in combination, it is essential to incorporate an appropriate skin care regimen to minimize local irritation. In the absence of direct comparative clinical trials, this review provides timely guidance for clinicians on the use of these agents, and their benefits in special populations.
J Drugs Dermatol. 2015;14(6):567-572.
We used pomegranate extract (POMx), pomegranate juice (POM juice) and green tea extract (GT) to establish in vitro activities against bacteria implicated in the pathogenesis of acne. Minimum inhibitory concentrations (MIC) of 94 Propionibacterium acnes, Propionibacterium granulosum, Staphylococcus aureus, and Staphylococcus epidermidis strains were determined by Clinical and Laboratory Standards Institute-approved agar dilution technique. Total phenolics content of the phytochemicals was determined using the Folin-Ciocalteu method and the polyphenol composition by HPLC. Bacteria were identified by 16S rRNA sequence analysis. GT MIC of 400 μg/ml or less was obtained for 98% of the strains tested. 64% of P. acnes strains had POMx MICs at 50 μg/ml whereas 36% had MIC >400 μg/ml. POMx, POM juice, and GT showed inhibitory activity against all the P. granulosum strains at ≤100 μg/ml. POMx and GT inhibited all the S. aureus strains at 400 μg/ml or below, and POM juice had an MIC of 200 μg/ml against 17 S. aureus strains. POMx inhibited S. epidermidis strains at 25 μg/ml, whereas POM juice MICs were ≥200 μg/ml. The antibacterial properties of POMx and GT on the most common bacteria associated with the development and progression of acne suggest that these extracts may offer a better preventative/therapeutic regimen with fewer side effects than those currently available.
J Drugs Dermatol. 2015;14(6):574-578.
INTRODUCTION: Routine use of doxycycline (DC) 100 mg for the treatment of moderate to severe acne may be associated with gastrointestinal
adverse events (AEs), thus potentially impacting patient adherence, and antibiotic resistance. This study evaluated the safety and efficacy of subantimicrobial, modified-release (MR) DC 40 mg compared to DC 100 mg and to placebo for the treatment of inflammatory lesions in moderate and severe acne.
METHODS: 662 subjects aged 12 years or older with moderate to severe acne received subantimicrobial, MR-DC 40 mg tablets, DC 100 mg capsules, or placebo once daily for 16 weeks.
RESULTS: MR-DC 40 mg was superior to placebo in the mean reduction of the number of inflammatory lesions, median percent reduction in inflammatory and total lesions, and success rate. MR-DC 40 mg was also comparable to DC 100 mg in the reduction of the number of inflammatory lesions, and percent reduction of total lesions. Incidence of drug-related AEs for MR-DC 40 mg was similar to placebo and was markedly smaller compared to DC 100 mg.
DISCUSSION: MR-DC 40 mg demonstrated comparable efficacy and superior safety to DC 100 mg in the treatment of moderate to severe inflammatory acne.
J Drugs Dermatol. 2015;14(6):581-586.
BACKGROUND: Acne vulgaris is one of the most common skin diseases treated by dermatologists. Salts of copper chlorophyllin complex are semi-synthetic naturally-derived compounds with antioxidant, anti-inflammatory and wound healing activity that have not been previously tested topically in the treatment of acne-prone skin with enlarged pores.
OBJECTIVES: This single-center pilot study was conducted to assess the efficacy and safety of a liposomal dispersion of topically applied sodium copper chlorophyllin complex in subjects with mild-moderate acne and large, visible pores over a course of 3 weeks.
METHODS: Subjects were supplied with the test product, a topical gel containing a liposomal dispersion of sodium copper chlorophyllin complex (0.1%) with directions to apply a small amount to the facial area twice daily. Clinical assessments were performed at screening/baseline and at week 3. VISIA readings were taken and self-assessment questionnaires were conducted.
RESULTS: 10 subjects were enrolled and completed the 3-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 3. The study product was well tolerated. Subject questionnaires showed the test product was highly rated.
CONCLUSIONS: In this pilot study, a topical formulation containing a liposomal dispersion of sodium copper chlorophyllin complex was shown to be clinically effective and well tolerated for the treatment of mild-moderate acne and large, visible pores when used for 3 weeks.
J Drugs Dermatol. 2015;14(6):589-592.
The objective of this study was to compare facial skin of adolescent males with (acne) and without acne (non-acne) over the course of 1 year. At study entry, presence of acne was determined by clinical image analysis (acne n=7, non-acne n=10). Monthly evaluations
of skin condition were made using standard and fluorescent imaging, fluorescence spectroscopic analysis, sebum analysis, skin high frequency conductivity (moisture content), transepidermal water loss (TEWL), and sampling of skin bacteria (aerobic and anaerobic). Data were evaluated seasonally. Over the course of the study, subjects in the acne and non-acne groups had no significant
increase in their clinical acne score. Sebum production was significantly greater in subjects with acne than in those without for each season examined (P<0.019) and was lowest in the winter and highest in the fall. TEWL was higher in those with acne than without
acne across all seasons (P=0.001). Skin moisture in both groups was increased during summer and fall compared with winter (P≤0.016 for both seasons). Subjects with acne had a higher recovery of both aerobic and anaerobic bacteria compared with subjects without acne (P≤0.015). Analysis of cheek skin in the nasal area revealed significantly higher fluorescence (500-800 nm) in image-based and spectroscopic analysis from subjects with acne, suggesting the greater presence of the bacterial metabolite porphyrin in those with acne. In these cohorts of adolescent males, significant differences in sebum production, skin barrier function, moisture content, and microbial load (anaerobic and aerobic) were noted between those with and without acne. Evidence for seasonality was observed, with lower lipid production and reduced barrier function during the winter. More studies to quantify differences in skin lipid components and bacterial species among these cohorts are planned.
J Drugs Dermatol. 2015;14(6):593-601.
BACKGROUND: We aimed to evaluate the effects of 5% dapsone gel compared with 0.75% metronidazole gel in the treatment of papulopustular rosacea.
METHODS: In a double-blind randomized clinical trial, 56 adult patients with papulopustular rosacea were enrolled. The severity of disorder was determined by the patient according to visual analogue score (VAS). Investigator’s global assessment (IGA) scores and number of inflammatory lesions were recorded. 5% dapsone gel was administered for group D and 0.75% metronidazole gel was administered for group M. Systemic doxycycline was administered for all patients. Follow-up assessments were done at 4, 8, and 12 weeks. Changes in VAS, IGA scores and number of lesions were evaluated. Intention to treat analysis was carried out using SPSS version 17 (Chicago, IL).
RESULTS: There was no significant difference in sex and age distribution between the two groups. Mean (SD) IGA score before and after intervention in group D was 3.9 (0.9) and 3.3 (0.9), respectively (P<0.0001). Mean (SD) IGA score before and after intervention in group M was 4.2 (1.2) and 3.6 (1.3), respectively (P<0.0001). Mean (SD) number of lesions before and after intervention in group D was 15 (7.4) and 11.1 (6), respectively (P<0.0001). Mean (SD) number of lesions before and after intervention in group M was 17.6 (7.7) and 12.5 (7.4), respectively (P<0.0001). Mean (SD) VAS score before and after intervention in group D was 6.6 (1.8) and 5.7 (1.9), respectively (P<0.0001). Mean (SD) VAS score before and after intervention in group M was 6.9 (2.0) and 5.3 (2.1), respectively (P<0.0001). Mean IGA score, mean number of lesions and mean VAS score were not significantly different between the two groups, whether before, during or after intervention.
CONCLUSION: Dapsone gel was as effective as metronidazole gel in the treatment of papulopustular rosacea.
J Drugs Dermatol. 2015;14(6):602-606.
An effective topical antifungal medication must penetrate through the nail plate at sufficient concentrations to eradicate the fungal infection. Tavaborole topical solution, 5% is a novel boron-based pharmaceutical approved for the treatment of toenail onychomycosis
due to Trichophyton rubrum or T mentagrophytes. Four in vitro studies assessed the antifungal activity and nail penetration of tavaborole. In Study 1, tavaborole demonstrated minimum inhibitory concentration (MIC) values ranging from 0.25–2 μg/mL against all fungi tested; addition of 5% keratin powder did not affect the MIC against T rubrum. The minimum fungicidal concentration (MFC) values for tavaborole against T rubrum and T mentagrophytes were 8 and 16 μg/mL, respectively. In Study 2, tavaborole effectively penetrated through the nail plate; mean concentrations in the ventral/intermediate nail layer were significantly higher than ciclopirox at day 15. In Study 3, mean cumulative tavaborole penetration through ex vivo human nails was significantly higher than ciclopirox at day 15. In Study 4, tavaborole demonstrated superior nail penetration and fungicidal activity, as measured by zones of inhibition. These studies demonstrated the superior penetration of tavaborole through the nail plate vs ciclopirox. Tavaborole demonstrated robust antifungal activity, with low MIC and MFC values, even in the presence of keratin.
J Drugs Dermatol. 2015;14(6):609-614.
BACKGROUND: Alopecia areata (AA) is considered a T-cell mediated autoimmune disease characterized by patchy loss of hair from scalp and other body parts with no definitive treatment. Calcipotriol is a vitamin D analogue and a potent immunomodulatuary molecule. In recent studies, low serum vitamin D levels have been observed in patients with AA and various autoimmune diseases. Previous reports have also described the effects of vitamin D on hair follicles.
OBJECTIVE : The aim of the study was to evaluate the efficacy and safety of topical calcipotriol for the treatment of mild-to-moderate patchy AA.
METHOD: Forty-eight patients with mild-to-moderate AA were enrolled in the retrospective, 12-week trial. Calcipotriol cream was applied to the affected areas twice a day. Severity of Alopecia Tool (SALT) score and hair regrowth rate were calculated at baseline and at 3, 6, 9, and 12 weeks.
RESULTS: At week 12, the total response was achieved in 69.2% of patients. When the mean SALT score of patients at week 12 was compared to that of patients at baseline, the value at week 12 was significantly lower (P= 0.001). A regrowth score (RGS) ≥ 3 (hair regrowth of ≥ 50%) was observed in 75% of patients, whereas a RGS ≥ 4 (hair regrowth of ≥ 75%) was observed in 62.5% of patients and the complete regrowth rate (hair regrowth= 100%) was 27.1%.
CONCLUSION: Calcipotriol may serve as a safe and effective treatment option in mild-to-moderate patchy AA, and calls for more extensive controlled studies with this treatment.
J Drugs Dermatol. 2015;14(6):616-620.