View clinical trials related to Acne Vulgaris.
Filter by:This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.
The proposed indication for GSK1940029 is topical treatment of acne, the early clinical plan will evaluate the irritation potential of GSK1940029 (Study SCD117225 - 3 Part study); and safety, tolerability and pharmacokinetics of GSK1940029 (Study SCD117226 - 2 Part study), after topical administration on healthy subjects and acne patients. Study SCD117226 will be a randomized, single-blind, dose-rising study to evaluate the safety, tolerability and preliminary pharmacokinetics of single and 14 day repeat topical applications of GSK1940029 gel on the intact skin of healthy human subjects. Part 1: (single-dose) subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as a single approximately (App) 24 hour (h) (22.5h) application to a surface area of 400 square centimeter (cm^2) (0.3%), 400 cm^2 (1%) or 1200 cm^2 (1%), respectively, in each of three sequential cohorts. Part 2: (repeat-dose) subjects will receive 0.3% or 1% GSK1940029 (or matching vehicle), as 14 daily App24h (22.5h) application to a surface area of 400 cm^2 (0.3%), 400 cm^2 (1%) or 1200 cm^2 (1%), respectively, in each of three sequential cohorts. Parts within Study SCD117225 and Study SCD117226 will have interdependencies. No significant primary irritation signal in Study SCD117225 Part 1 (primary irritation) would allow initiation of Study SCD117226 Part 1. Once safety, tolerability and exposure information are determined in Study SCD117226 Part 1, then Part 2 (cumulative irritation) of Study SCD117225 may be initiated along with Part 2 of Study SCD117226. No significant cumulative irritation signal (study SCD117225 Part 2) in combination with adequate 14-day safety (study SCD117226 Part 2) would allow initiation of Part 3 (facial irritation) of Study SCD117225.
This is a Phase 1/2a study. The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers. The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.
Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that may impair neurocognitive functions such as memory, attention, psychomotor speed, and executive functions, which are also common psychiatric disorders in patients with acne. The purpose of this study is to determine cognitive functioning in treatment naive acne patients, without a history of any psychiatric disorder.
In an 8 week double blind randomized controlled split-face studies, we tried to compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO) Basically, this is a split face study - one side of face randomly assigned was applied with LFCO and the other side with TTO in same patients.
Clindamycin 1.0% - tretinoin 0.025% gel (CT Gel) is a reformulation of VELAC Gel that contains the same active ingredients (clindamycin 1.0% and tretinoin 0.025%) in a modified vehicle. This was a single-center, evaluator-blinded, randomized, placebo (vehicle)-controlled phase 1 study to evaluate the phototoxic potential of CT Gel using 24 hour single applications of 3 sets of 3 study patches. The study expected to enroll approximately 40 healthy adult volunteers. Each set of study patches consisted of a CT Gel patch, a vehicle gel patch, and a blank patch (did not contain CT Gel or vehicle gel). After concurrent 24-hour single applications of all 9 patches, 1 set of patches (set A) was removed, and those sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) and 0.75 minimal erythema dose (MED) with UVA/ultraviolet B light (UVB). The second set of patches (set B) was removed, and those sites were irradiated with 16 joules/cm2 of UVA, 0.75 MED with UVB/UVA, followed by 15 joules/cm2 of visible light (VIS). The third set of patches (set C) was then removed, and those sites served as a non irradiated control. Inflammatory responses and other cutaneous effects were scored 1 hour after patch removal and during follow-up visits at 24, 48, and 72 hours after patch removal.
The purpose of this study is to determine the response of acne patients and healthy control patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1 to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects for further analysis in the lab to determine whether the inflammation in these pimples can be reduced using anti-P.acnes antibodies.
This was a single-center, evaluator-blinded, randomized, placebo (vehicle) -controlled phase I study to evaluate the photoallergic potential of Clindamycin-Tretinoin Gel. The design consisted of the following periods: screening, induction, rest, challenge, and rechallenge (if indicated). Induction visit 1 was to occur within 5 days of screening visit 2. The study expected to enroll approximately 62 healthy adult volunteers. Subjects were to receive repeated 24-hour study patch applications; after patch removal, the sites were irradiated with ultraviolet B light (UVB) and visible light (VIS) during the induction period (consisting of 6 consecutive induction phases), and ultraviolet A light (UVA)/ UVB and VIS during the challenge and rechallenge periods. Each application site was observed approximately 1, 24, 48, and 72 hours later for signs of inflammation.
This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45 years of age, inclusive, at the time of consent, who have mild to moderate facial acne vulgaris. Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will be evaluated for change in lesion counts, investigator's static global assessment (ISGA), subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit.
This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.