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临床试验/CTRI/2025/05/087032
CTRI/2025/05/087032招募中不适用

A prospective, randomized, double blind, two arms, comparative clinical study to evaluate the safety and efficacy of Nixoderm tin in the management of acne vulgaris in adult subjects.

M/s.SC Johnson & Son Nigeria Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月26日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Primary Outcomes:

研究概览

简要总结

Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. The pathogenesis of acne vulgaris involves the interaction of multiple factors that ultimately lead to the formation of its primary lesion, which is known as "comedo". Although acne vulgaris is commonly observed among adolescents, it is not restricted to this age group and can affect individuals of various ages. The severity of this condition can vary, ranging from a mild presentation with only a few comedones to more severe forms characterized by disfiguring inflammatory manifestations, which can lead to hyperpigmentation, scarring, and adverse psychological effects.Acne vulgaris is commonly observed in adolescents and young adults. Its prevalence rates are estimated to range from 35% to over 90% among adolescents. The natural course of this disease can commence as early as ages 7-12 (preadolescent acne) and resolve by the third decade of an individual’s life. However, there are instances where acne can persist into adulthood or even develop for the first time during adulthood.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Aged between 18-65 years
  • Both male and female
  • Participants diagnosed with acne vulgaris on face with mild to moderate severity
  • Willing to give Informed Consent.
  • Willing to complete the study assessments/questionnaires.
  • Willing to avoid usage of his/her own skin care products for at least one week before the commencement and during this study.

排除标准

  • Pregnancy or breast feeding.
  • Participants with history of hypersensitivity to skin care products.
  • Participants with mild to severe anaphylaxis reaction.
  • Participants with pre-existing severe systemic disease necessitating long term medication.
  • Participants with any other concomitant skin diseases such as psoriasis, eczema etc.
  • Evidence of significant uncontrolled co-morbid disease which in the investigators opinion would jeopardize patient participation.
  • History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
  • Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.

结局指标

主要结局

Primary Outcomes:

时间窗: Day 0,Day 7,Day 15,Day 30.

• Acne quality of life index

时间窗: Day 0,Day 7,Day 15,Day 30.

questionnaire (AQOLI) questionnaire

时间窗: Day 0,Day 7,Day 15,Day 30.

• Sebumeter

时间窗: Day 0,Day 7,Day 15,Day 30.

• Global Acne Grading System (GAGS)

时间窗: Day 0,Day 7,Day 15,Day 30.

次要结局

  • Dermatological Assessments(Day 7,Day 15,Day 30.)

研究者

发起方
M/s.SC Johnson & Son Nigeria Ltd
申办方类型
Other [[Cosmetic Industry]]

研究点 (1)

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