Combined Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Trichloroacetic acid peel
combined azaleic and salicylic acids
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, Chemical peeling, Dermoscopy
Eligibility Criteria
Inclusion Criteria:
- any patients with active acne
Exclusion Criteria:
- Pregnancy.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
combined azaleic and salicylic acids
Trichloroacetic acid peel
Arm Description
Combined azaleic acid 20% with salicylic acid 20% peel every 2 weeks for 4 sessions
Trichloroacetic acid 25% peel every 2 weeks for 4 sessions
Outcomes
Primary Outcome Measures
Change in acne lesions count
Change from baseline inflammatory and non-inflammatory lesions count at 2 months
Secondary Outcome Measures
change in acne erythema grading
Change from baseline acne erythema grading using dermoscopy at 2 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03071549
Brief Title
Combined Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Acne
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne vulgaris, Chemical peeling, Dermoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combined azaleic and salicylic acids
Arm Type
Active Comparator
Arm Description
Combined azaleic acid 20% with salicylic acid 20% peel every 2 weeks for 4 sessions
Arm Title
Trichloroacetic acid peel
Arm Type
Active Comparator
Arm Description
Trichloroacetic acid 25% peel every 2 weeks for 4 sessions
Intervention Type
Drug
Intervention Name(s)
Trichloroacetic acid peel
Intervention Description
Skin degreasing will be performed before every session using acetone. Trichloroacetic acid 25% will be applied on one side of the face.
Intervention Type
Drug
Intervention Name(s)
combined azaleic and salicylic acids
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in acne lesions count
Description
Change from baseline inflammatory and non-inflammatory lesions count at 2 months
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
change in acne erythema grading
Description
Change from baseline acne erythema grading using dermoscopy at 2 months
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
any patients with active acne
Exclusion Criteria:
Pregnancy.
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Acne
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