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临床试验/CTRI/2026/04/109478
CTRI/2026/04/109478尚未招募4 期

A Randomized Controlled Trial comparing Topical Adapalene Benzoyl Peroxide Clindamycin Combination versus Topical Adapalene Benzoyl Peroxide Combination in Treatment of Mild to Moderate Acne

AIIMS Jammu1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2026年5月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
168
试验地点
1

研究概览

简要总结

Randomized, evaluator blinded, parallel group clinical trial aims to compare effectiveness and safety of fixed-dose combination of Adapalene, Benzoyl Peroxide and Clindamycin with Adapalene and Benzoyl Peroxide therapy in patients with mild to moderate acne vulgaris. Participants will be randomly allocated to one of the two treatment groups. Clinical improvement will be assessed using standardized acne severity grading scales at baseline and follow-up visits.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
12.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Male and female patients aged 12-45 years.
  • Clinical diagnosis of mild (few inflammatory lesions (papules/pustules) only; no nodulocystic lesions; IGA score 2) to moderate (multiple inflammatory lesions present; many papules/pustules; there may or may not be a few nodulocystic lesions, IGA score 3) acne vulgaris.
  • Willingness to avoid use of other acne medications during the study.
  • Written informed consent obtained.

排除标准

  • Severe acne (Inflammatory lesions are more apparent, many papules,pustules; there may or may not be a few nodulocystic lesions; IGA 4 or more.
  • Presence of nodulocystic, conglobate, or acne fulminans variants.
  • Clinical or biochemical features suggestive of hormonal acne, such as polycystic ovarian syndrome (PCOS) or hyperandrogenism.
  • Use of topical or systemic retinoids, corticosteroids, antibiotics, or hormonal therapy within the previous 4 weeks.
  • Pregnant or lactating women.
  • Known hypersensitivity to study medications.
  • Presence of systemic illness, immunocompromised state, or chronic dermatologic conditions affecting the face.
  • History of drug induced acne or use of comedogenic cosmetic products.

研究者

发起方
AIIMS Jammu
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Nasna V

AIIMS Jammu

研究点 (1)

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