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Trial record 1 of 142 for:    acne AND erythema
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Combined Salicylic and Azaleic Acid Verus Trichloroacetic Acid 25% Peel in Treatment of Acne

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ClinicalTrials.gov Identifier: NCT03071549
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Rania Abdel hay, Cairo University

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Trichloroacetic acid peel Drug: combined azaleic and salicylic acids Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.




Primary Outcome Measures :
  1. Change in acne lesions count [ Time Frame: 8 weeks ]
    Change from baseline inflammatory and non-inflammatory lesions count at 2 months


Secondary Outcome Measures :
  1. change in acne erythema grading [ Time Frame: 2 months ]
    Change from baseline acne erythema grading using dermoscopy at 2 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Rania Abdel hay, Associate professor of dermatology, Cairo University
ClinicalTrials.gov Identifier: NCT03071549     History of Changes
Other Study ID Numbers: Dermatology REC 3/2016
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rania Abdel hay, Cairo University:
Acne vulgaris
Chemical peeling
Dermoscopy

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Salicylic Acid
Salicylates
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action