Clinical and Dermoscopic Study Using a Combination of Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Mild to Moderate Acne , A Split Face, Double Blinded, Randomised Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 34
- Primary Endpoint
- Change in acne lesions count
Study Overview
Brief Summary
Acne patients were included in this randomized controlled trial. Each patient received four treatment sessions two weeks apart. 20% azelaic acid combined with 20% salicylic acid were applied to the one side of the face while 25% trichloroacetic acid was applied to the other side. Evaluation was done by counting number of non-inflammatory and inflammatory lesions before, after two and after four treatment sessions. The dermoscope was used in evaluating the degree of improvement of erythema.
Detailed Description
This study included 34 patients with mild and moderate acne vulgaris. The patients were recruited from the dermatology outpatient clinic of Kasr AlAiny hospital.
This study was approved by the Ethical committee of the Faculty of Medicine Cairo University and the Ethical committee of the Dermatology department Cairo University.
After signing an informed consent, patients were subjected to history taking, clinical examination and grading of their acne by global acne grading score, photography, dermoscopic examination and chemical peeling.
Photography:
Patient was photographed from front, lateral and side view before each session and two weeks after the 4th session. All photographs were taken using a digital camera (Nikon AW1, Indonesia) with identical lightening and patient positions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •any patients with active acne
Exclusion Criteria
- •History of oral herpes simplex virus.
- •History of keloid formation.
- •Associated autoimmune disease (e.g vitiligo, systemic lupus erythematosus).
- •History of past medications in the last six months.
- •Patient unable to perform necessary postoperative care
Arms & Interventions
combined azaleic and salicylic acids
Combined azaleic acid 20% with salicylic acid 20% peel every 2 weeks for 4 sessions
Intervention: combined azaleic and salicylic acids (Drug)
Trichloroacetic acid peel
Trichloroacetic acid 25% peel every 2 weeks for 4 sessions
Intervention: Trichloroacetic acid peel (Drug)
Outcomes
Primary Outcomes
Change in acne lesions count
Time Frame: 8 weeks
Change from baseline inflammatory and non-inflammatory lesions count at 2 months
Secondary Outcomes
- change in acne erythema grading(2 months)
Investigators
Rania Abdel hay
Associate professor of dermatology
Cairo University