Comparative study between efficacy of 18 percent Salicylic acid and 15 percent Azelaic acid combination peel vs 20 percent Salicylic acid and 10 percent Mandelic acid combination peel in Acne vulgaris grade II & III - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in lesions of acne vulgaris with both Salicylic Acid + Mandelic Acid and Salicylic Acid + Azelaic Acid combination peels using IAA (Indian Acne Alliance) grading of acne.
研究概览
简要总结
One of the most common illnesses affecting adolescents is acne vulgaris. It causes discomfort on a physical and psychological level and is typified by the development of lesions with or without pigmentation and scarring, usually over the face but occasionally over the trunk. Different oral and topical drugs, as well as techniques including chemical peeling and microneedling, are used to treat it. One safe and efficient way to treat this issue is chemical peeling.
In this randomised controlled experiment, the effectiveness of two different peeling techniques—Group 1 using a combination of 18% salicylic acid and 15% azelaic acid and Group 2 using a combination of 20% salicylic acid and 10% mandelic acid—in treating Acne vulgaris grades II and III is being compared. On the initial visit, which will serve as the baseline, the participants will be rated in accordance with the Indian Acne Alliance (IAA) grading system. Following then, they will be checked on every two weeks for a maximum of six sittings, or until they attain grade I, whichever comes first, with each visit involving grading. The significance difference for comparison groups at the 5% level (P<=0.05) will be determined using the T-test. The active control group consisted of salicylic acid plus azelaic acid combination peel, while the experimental group consisted of salicylic acid plus mandelic acid combination peel. The IAA grade of acne, which is a categorical variable, will be evaluated using the Fisher exact test to determine the significance of the correlation at various risk variables. Multivariate analysis will be used to examine all confounding variables.
The Scientific Scrutiny/Institutional Research Committee and the Institutional Ethics Committee (IEC) have both approved. Every participant will be required to provide written, informed consent, and both during and after the study, the privacy of their personal data will be guaranteed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients above 18 years of age.
- •Patients who have given written consent before any treatment is commenced.
- •Clinically Diagnosed cases of acne vulgaris grade II & grade III.
排除标准
- •Patients with active herpes simplex infection, viral warts, molluscum contagiosum or any other local site infection.
- •Patients who are on systemic medication for acne vulgaris for the past 3 months or topical medication for the past 1 month.
- •Patient on photosensitive drugs like tetracyclines.
- •Patients with history of hypertrophic scars and keloid.
- •Patients with unrealistic expectations.
结局指标
主要结局
Reduction in lesions of acne vulgaris with both Salicylic Acid + Mandelic Acid and Salicylic Acid + Azelaic Acid combination peels using IAA (Indian Acne Alliance) grading of acne.
时间窗: Will be assessed at baseline, then every 2 weeks till maximum 6 sittings
次要结局
- Time required to achieve grade I in case of both the peels(Will be assessed at baseline, then every 2 weeks till maximum 6 sittings)
研究者
Dr Bhakti Sarda
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research
