Comparison of Topical Clascoterone and Adapalene for Mild Acne Vulgaris

Официальное название

Comparison of Efficacy of Topical Clascoterone With Topical Adapalene in the Treatment of Mild Acne Vulgaris

Обзор

There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient outcomes and better utilization of healthcare resources. Furthermore, the study will contribute local data to the existing literature and may assist in developing evidence-based treatment recommendations for patients with mild acne vulgaris in our setting. Patients meeting the inclusion criteria from the Dermatology Unit, Khyber Teaching Hospital, MTI, Peshawar will be incorporated into the study following approval from the ethics committee. At the commencement of the trial, baseline demographics including gender, age, height, weight, BMI, duration of acne, socioeconomic status, profession, monthly income, education level and residential status will be documented. An elaborate explanation of the process involved in the study will be provided to the participants, and consent will be taken following an explanation of the pros and cons involved. Randomization will be performed by computer generated random list. The group assignments will be put into sealed envelopes, which will be opened when the patient will be included in study. 30 patients will be in topical clascoterone group (A) while 30 patients will be in topical adapalene group (B). Patients allocated to Group A will receive topical clascoterone 1% cream. It is required that they will clean their faces using a mild cleansing agent, dry their faces and thereafter apply a thin coating of clascoterone 1% cream to their whole face area in the morning and evening for 12 consecutive weeks. Patients allocated to Group B will receive topical adapalene 0.1% gel. Patients will cleanse the skin using a gentle cleanser, allow it to dry in the air for 10 minutes, and then apply one pea-sized amount of 0.1% adapalene gel over their entire affected area of the face once a day before going to bed for 12 weeks.

Вмешательства

• Препарат Clascoterone Cream 1%
  Participants in this group will apply topical clascoterone 1% cream to the affected areas as prescribed for the duration of the study.
• Препарат Adapalene 0,1% cgel
  Participants in this group will apply topical adapalene 0.1% gel to the affected areas as prescribed for the duration of the study.

Первичные конечные точки

• IGA achievement [Срок оценки: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.]
• Achievement of and IGA score of 0(clear) or 1(almost clear) after 12 weeks of treatment [Срок оценки: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.]

Критерии участия

Критерии включения

• Clinical diagnosis of mild acne vulgaris as per operational definition
• Male or female patients
• Age 12 to 35 years

Критерии исключения

• History of acne conglobata
• History of acne fulminans
• Use of topical anti-acne medications within the last 4 weeks
• Use of systemic anti-acne therapy within the last 12 weeks
• Known hypersensitivity or allergy to clascoterone or adapalene
• History of eczema
• History of rosacea
• History of seborrheic dermatitis
• History of psoriasis
• Presence of active skin infections
• Pregnant women
• Lactating women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Morshed ASM, Noor T, Uddin Ahmed MA, Mili FS, Ikram S, Rahman M, Ahmed S, Uddin MB. Understanding the impact of acne vulgaris and associated psychological distress on self-esteem and quality of life via regression modeling with CADI, DLQI, and WHOQoL. Sci Rep. 2023 Nov 30;13(1):21084. doi: 10.1038/s41598-023-48182-6. PMID 38030667
• Vasam M, Korutla S, Bohara RA. Acne vulgaris: A review of the pathophysiology, treatment, and recent nanotechnology based advances. Biochem Biophys Rep. 2023 Nov 23;36:101578. doi: 10.1016/j.bbrep.2023.101578. eCollection 2023 Dec. PMID 38076662

Идентификаторы

NCT: NCT07673094 · 383/IREB/KTH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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