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临床试验/CTRI/2023/10/059321
CTRI/2023/10/059321尚未招募2/3 期

To Compare The Therapeutic Efficacy Of Lactosporin 2% Gel Versus Adapalene 0.1% Gel In The Treatment Of Mild To Moderate Acne Vulgaris- A Randomized Comparative Study

Vinayaka Missions Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月11日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Compare the clinical response with the help of Global acne grading system and comparing the therapeutic efficacy of Adapalene 0.1% Gel versus Lactosporin 2% Gel in the treatment of mild to moderate Acne Vulgaris

研究概览

简要总结

Clinical diagnosis will be made based on detailed history and examination

After applying Inclusion and exclusion criteria patients will be selected for the study. History and written consent from the patient is taken

For Group A patients :- The patients will be advised to apply Lactosporin 2% Gel twice a day (morning and night) for 4 weeks. Follow up will be done every week

For Group B patients :- The patients will be advised to apply Adapalene 0.1% Gel once a day (at night). Follow up will be done every week

The dermatological assessment will be performed using the Global acne grading system at the beginning of the study and then weekly.

Patients of both groups will be followed up for a period of 4 weeks after cessation of treatment, to check for any recurrence

The study will be concluded with the comparison of clinical improvement of both Group A and Group B study population

研究设计

研究类型
Interventional
分配方式
Stratified randomization
盲法
Open Label

入排标准

年龄范围
16.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Patients with Mild to moderate acne vulgaris 2)Patients willing to participate in the study.

排除标准

  • Pregnant and lactating mothers 2)Patients allergic to Lactosporin and Adapalene 3)Patients who used topical corticosteroids ,antibiotics or retinoids within the past two weeks on the face 4)Patients who used systemic corticosteroids, antibiotics or retinoids within the past 1 month.

结局指标

主要结局

Compare the clinical response with the help of Global acne grading system and comparing the therapeutic efficacy of Adapalene 0.1% Gel versus Lactosporin 2% Gel in the treatment of mild to moderate Acne Vulgaris

时间窗: Every week during the course of treatment, at the end of 4 weeks of treatment

次要结局

  • Treatment side effects,(Recurrence)

研究者

申办方类型
Private medical college

研究点 (1)

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