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临床试验/CTRI/2025/09/094900
CTRI/2025/09/094900尚未招募不适用

A multi-action anti acne formulation using Tretinoin, Niacinamide, Zinc and Azadirachta Indica.

Dr. Palchuri Sneha Ananya1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年9月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
Reduction in lesion count, change in acne severity score

研究概览

简要总结

Acne is a chronic, self-limiting, inflammatory disease of the pilosebaceous unit, manifesting generally in adolescence with pleomorphic lesions like comedones, papules, pustules, nodules, and cysts and these may lead to scarring. At present Tretinoin has been primarily used for the early stages of acne because of its proven comedolytic benefits and it’s ability to stimulate the growth of new cells, unclog pores and promote the normal flow of sebum, but due it’s irritant effects like redness and dry skin the compliance rate is low. Addition of niacinamide will reduce the irritant effects by hydrating the skin, enhancing skin barrier and reducing the risk of irritation caused by retinol. Niacinamide on it’s own has an anti inflammatory effect that helps in reduction of acne and redness. Niacinamide by decreasing the sebum production, decreases acne breakouts. It also reduces hyperpigmentation by inhibiting enzymes involved in the production of melanin thus helping in reduction of post acne hyperpigmentation and blemishes. Zinc due to it’s anti microbial properties exerts a direct inhibitory action on “acne causing bacteria” and reduces sebum production adding a synergistic effect to Niacinamide. Anti inflammatory and anti microbial properties of neem add to the synergistic effect and reduce acne breakouts.

Thus a combination of Tretinoin, Niacinamide, Zinc, Neem combats acne effectively eliminating irritant effects of tretinoin. This formulation thus increases the compliance of treatment in patients allowing in effective reduction of acne and increasing self esteem of the patients

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Mild to moderate acne vulgaris based on clinical diagnosis.
  • Willingness to comply with study procedures and provide informed consent.

排除标准

  • Pregnant or lactating women
  • Severe nodular or cystic acne requiring systemic treatment.
  • Use of systemic Retinoids, Corticosteroids, or other acne treatments in past 5 months that could affect study outcomes.
  • Known allergies or sensitivity to any ingredientsin the study formulation.
  • Unwilling to comply with study procedures.

结局指标

主要结局

Reduction in lesion count, change in acne severity score

时间窗: 3 months

次要结局

  • Tolerability and safety profile(3 months)

研究者

发起方
Dr. Palchuri Sneha Ananya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Palchuri Sneha Ananya

Saveetha medical college and hospital, Saveetha institute of medical and technical sciences.

研究点 (1)

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