Effectiveness and safety of once-daily doxycycline capsules as monotherapy in patients with rosacea: an analysis by Fitzpatrick skin type.

Rosacea is often under-recognized or misdiagnosed in patients with skin of color (Fitzpatrick Skin Types [FST] IV-VI). Subtle clinical features and a low index of suspicion likely contribute to less frequent diagnosis in this population. Clinical trials of therapeutic agents for rosacea generally include few patients from nonwhite racial/ethnic groups and therefore, potential differences in treatment outcomes have not been previously studied. The objective of this prospective analysis was to fill the gap in knowledge of the effectiveness and safety of treatment for rosacea in patients with skin of color. We analyzed data from 826 adults aged ≥ 18 years with papulopustular (subtype 2) rosacea (663 FST I-III; 163 FST IV-VI). All patients received doxycycline 40 mg capsules (30 mg immediate release and 10 mg delayed release beads) once daily as monotherapy for 12 weeks in this open-label, multicenter, community-based study. Investigators assessed disease severity with the Investigator's Global Assessment (IGA) and erythema with the Clinician's Erythema Assessment (CEA). Significant improvement in disease severity and erythema was obtained in patients with FST I-III and IV-VI at week 12 (P<.001). Treatment success, defined as an IGA score of 0 or 1 was achieved in 74.6% and 74.3% of patients with FST I-III and IV-VI, respectively. Approximately 12% of patients experienced adverse events with no difference between the two skin type groups. The results of this prospective subgroup analysis of data from a large community-based trial suggest that doxycycline produced similar effectiveness and safety profiles in patients with FST I-III and IV-VI.

Impact of clobetasol propionate 0.05% spray on health-related quality of life in patients with plaque psoriasis.

Psoriasis causes significant distress and impairment in health-related quality of life (QOL) in afflicted patients. For this reason, QOL is an essential and important measure of treatment outcome in patients with the disease. Clobetasol propionate is a super-highpotent class I topical corticosteroid. The spray formulation is approved for twice-daily use for up to 4 weeks by patients 18 years and older with moderate to severe plaque psoriasis. Data collected from 2,236 patients enrolled in 5 clinical trials demonstrate consistent improvement in QOL measures using multiple instruments. In a randomized, double-blind trial in patients with scalp psoriasis, treatment with clobetasol propionate 0.05% spray produced significantly greater improvement in QOL compared with vehicle, as measured by the Scalpdex QOL instrument. In another randomized trial in patients with moderate to severe plaque psoriasis, clobetasol propionate 0.05% spray produced significantly greater reductions in mean affected body surface area and significantly greater improvements in QOL, as measured by the Dermatology Life Quality Index (DLQI), compared with a 0.05% foam formulation. When compared with calcipotriene/betamethasone dipropionate ointment, clobetasol propionate 0.05% spray produced greater rates of lesion clearance and similar improvement in QOL scores after 2 or 4 weeks of treatment. When clobetasol propionate 0.05% spray was used as monotherapy or as an add-on therapy for 4 weeks in a large, observational trial, approximately 80% of patients experienced consistent and significant improvement in QOL on 2 separate, validated QOL instruments (DLQI and the Koo-Menter Psoriasis Index). In conclusion, clobetasol propionate 0.05% spray is an efficacious and safe treatment for plaque psoriasis and produces significant improvement in QOL for affected patients.

Digital videography assessment of patients' experiences using adapalene-benzoyl peroxide gel in the treatment of acne vulgaris.

BACKGROUND: Acne profoundly affects patients' lives, but the effect of treatment is not fully characterized. OBJECTIVE: The purpose of this study was to explore patients' experiences and viewpoints regarding treatment for mild to moderate acne vulgaris. METHODS: This was an open-label, single-center study of 30 patients with mild to moderate acne vulgaris, treated with adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO gel) once daily for 12 weeks. An acne-specific quality of life questionnaire (Acne-QoL©) was conducted. Each subject's global assessment (SGA) was recorded at baseline and weeks 4, 8, and 12. Photographs were taken and video interviews were recorded. Local tolerability assessments and incidence of adverse events were documented. RESULTS: A statistically significant number of patients were clear/almost clear (treatment success) at week 12 (P<.001). At week 12, patients experienced a 44.1% and 57.1% mean reduction in inflammatory and noninflammatory lesions, respectively. By week 12, 67% of the patients in the video population (n=27) believed they had achieved treatment success (P<.001). Patients reported higher Acne-QoL© scores at week 12 compared to baseline, indicating better quality of life after treatment with adapalene-BPO gel (P<.001 for all domains). No unexpected adverse or serious adverse events were reported. LIMITATIONS: This was an open-label study of 12 weeks duration. CONCLUSION: Overall, patients with mild to moderate acne treated with adapalene-BPO gel showed significant improvement in disease severity and quality of life. The video recordings chronicled the patients' experiences throughout the treatment process.

Effectiveness and safety of modified-release doxycycline capsules once daily for papulopustular rosacea monotherapy results from a large community-based trial in subgroups based on gender.

This article is a prospective planned analysis of data evaluating the effectiveness and safety of modified-release doxycycline capsules (30 mg immediate-release and 10 mg delayed-release beads) used once daily for up to 12 weeks in subgroups of males and females with papulopustular (subtype 2) rosacea from a large, open-label, multicenter, community-based study. A total of 1421 patients participated in the study. The per-protocol population comprised 826 patients on monotherapy, with 28.5% male participants (n=235) and 71.5% female participants (n=591). Rosacea was assessed on a 5-point investigator's global assessment (IGA) scale (0=clear, 1=near clear, 2=mild, 3=moderate, 4=severe). Erythema was also assessed on a 5-point clinician's erythema assessment (CEA) scale (0=none, 1=mild, 2=moderate, 3=significant, 4=severe). At baseline, males had a higher percentage of IGA scores of 3 (116 per 235; 49.4% versus 273 per 591; 46.2% in females) and 4 (32 per 235; 13.6% versus 35 per 591; 5.9% in females). Significant improvements in severity rating and erythema were observed in males and females as demonstrated by shifts in the distribution of IGA and CEA scores between baseline and week 12 (P<.001). Treatment success (IGA score of 0 or 1) at week 12 was achieved in 172 per 235 (73.2%) of males and in 444 per 591 (75.2%) of females. Adverse events (primarily mild or moderate gastrointestinal events) were reported in 9.9% of males and 12.8% of females. Anti-inflammatory dose doxycycline, which is administered as a 40 mg modified-release capsule once daily was effective and safe as monotherapy for papulopustular rosacea in both the female (n=591) and male (n=235) study groups. This specific 40 mg capsule delivers 30 mg immediate-release and 10 mg as delayed release using specially designed beads, and is subantimicrobial with both single and repeated dosing.

Clobetasol propionate 0.05% spray for the management of moderate-to-severe plaque psoriasis of the scalp: results from a randomized controlled trial.

BACKGROUND: Clobetasol propionate 0.05% spray is available for treating moderate-to-severe plaque psoriasis; however, there is limited information with plaque psoriasis of the scalp. OBJECTIVE: Evaluate the efficacy, safety, and quality-of-life impact of clobetasol propionate 0.05% spray in patients with moderate to severe plaque psoriasis of the scalp. METHODS: Multicenter, randomized, double-blind, vehicle-controlled study involving 81 men and women with moderate-to-severe (Global Severity Score [GSS] = 3 or 4) plaque psoriasis of the scalp. Eligible patients were treated with clobetasol propionate 0.05% spray or vehicle spray, which was applied twice daily for up to four weeks. The primary efficacy end point was the GSS of psoriasis of the scalp after four weeks. Safety assessments included local tolerability, presence of Cushing's syndrome, and adverse events. RESULTS: At the end of treatment, 85 percent (35/41) of patients in the clobetasol propionate 0.05% spray group achieved success (GSS clear or almost clear), compared with 13 percent (5/40) in the vehicle spray group (P is less than .001). The proportion of patients treated with clobetasol propionate 0.05% spray who achieved a rating of clear (GSS = 0) after two weeks and at the end of treatment was 12 percent and 51 percent, respectively. Clobetasol propionate 0.05% spray was well tolerated, and there were no serious adverse events or reported cases of folliculitis or Cushing's syndrome. CONCLUSION: Treatment with clobetasol propionate 0.05% spray for up to four weeks is effective and well tolerated for moderate-to-severe plaque psoriasis of the scalp.