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
1 other identifier
interventional
34
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2016
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 26, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedMarch 7, 2017
March 1, 2017
4 months
February 26, 2017
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in acne lesions count
Change from baseline inflammatory and non-inflammatory lesions count at 2 months
8 weeks
Secondary Outcomes (1)
change in acne erythema grading
2 months
Study Arms (2)
combined azaleic and salicylic acids
ACTIVE COMPARATORCombined azaleic acid 20% with salicylic acid 20% peel every 2 weeks for 4 sessions
Trichloroacetic acid peel
ACTIVE COMPARATORTrichloroacetic acid 25% peel every 2 weeks for 4 sessions
Interventions
Skin degreasing will be performed before every session using acetone. Trichloroacetic acid 25% will be applied on one side of the face.
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.
Eligibility Criteria
You may qualify if:
- any patients with active acne
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of dermatology
Study Record Dates
First Submitted
February 26, 2017
First Posted
March 7, 2017
Study Start
April 1, 2016
Primary Completion
August 1, 2016
Study Completion
November 1, 2016
Last Updated
March 7, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share