Combined Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Acne
|ClinicalTrials.gov Identifier: NCT03071549|
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Trichloroacetic acid peel Drug: combined azaleic and salicylic acids||Phase 3|
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.
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.
The cheek was split as four quadrants and photography of dermoscopic figures was taken before every session and two weeks after the 4th session (Using Dermalite DL3N Gen, USA).
Skin degreasing was performed before every session using acetone. Trichloroacetic acid 25% was applied on one side of the face and azaleic acid 20% with salicylic acid 20% to the other side of the face randomly. Randomization was done through a computer-generated random sequence prepared by a statistician; Allocation was concealed in sequentially numbered, sealed, opaque envelopes, and kept by a nurse not involved in the study.
A gauze was used to apply the peel. The gauze was soaked with the peel. The peel was applied uniformly starting from medial to lateral. The peel was left on each side for around 60 seconds. The patients were asked to wash their faces using tape water for neutralization of the peel until the burning sensation is eliminated.
Patients received 4 sessions 2 weeks apart. As a post procedure care, the patients were asked to apply sun screens immediately after the procedure until their next session.
No other topical or systemic treatment was used during sessions. Patients will receive 4 peeling sessions 2 weeks apart.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||RCT|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||November 2016|
Active Comparator: combined azaleic and salicylic acids
Combined azaleic acid 20% with salicylic acid 20% peel every 2 weeks for 4 sessions
Drug: combined azaleic and salicylic acids
Skin degreasing will be performed before every session using acetone. Azaleic acid 20% with salicylic acid 20% will be applied to the other side of the face.
Active Comparator: Trichloroacetic acid peel
Trichloroacetic acid 25% peel every 2 weeks for 4 sessions
Drug: Trichloroacetic acid peel
Skin degreasing will be performed before every session using acetone. Trichloroacetic acid 25% will be applied on one side of the face.
- Change in acne lesions count [ Time Frame: 8 weeks ]Change from baseline inflammatory and non-inflammatory lesions count at 2 months
- change in acne erythema grading [ Time Frame: 2 months ]Change from baseline acne erythema grading using dermoscopy at 2 months