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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, Chemical peeling, Dermoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    February 26, 2017
    Last Updated
    March 1, 2017
    Sponsor
    Cairo University
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    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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