Combined Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Acne

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: combined azaleic and salicylic acids; Drug: Trichloroacetic acid peel

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.

Dermoscopy:

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).

Chemical peeling:

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
• Enrollment (Actual): 34
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• any patients with active acne

Exclusion Criteria:

1. Pregnancy.
2. History of oral herpes simplex virus.
3. History of keloid formation.
4. Associated autoimmune disease (e.g vitiligo, systemic lupus erythematosus).
5. History of past medications in the last six months.
6. Patient unable to perform necessary postoperative care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in acne lesions count	Change from baseline inflammatory and non-inflammatory lesions count at 2 months	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in acne erythema grading	Change from baseline acne erythema grading using dermoscopy at 2 months	2 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 26, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Acne vulgaris; Dermoscopy; Chemical peeling
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid; Salicylates
• Other Study ID Numbers: Dermatology REC 3/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No