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The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars

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ClinicalTrials.gov Identifier: NCT02126657
Recruitment Status : Unknown
Verified April 2014 by National University Hospital, Singapore.
Recruitment status was:  Not yet recruiting
First Posted : April 30, 2014
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:

Our study involves the evaluation of a high potency chemical peel in its efficacy and safety profile for the treatment of acne scars. This chemical peel regime is a high potency peel of 70% glycolic acid combined with vitamin C that is purported to provide a good balance between yielding results and patient safety. We aim to evaluate its efficacy and safety profile of a single application. The study design is based on a single group that compares pre- vs post-intervention. 10 patients with atrophic acne scars of skin type I-IV will be recruited. Potential benefits include improvement of post acne scars with a short downtime and risks include post peel hyper pigmentation and scarring. We believe that this treatment will be highly beneficial to patients with post acne scarring.

This chemical peel regime has good efficacy and safety profile for the treatment of acne scars.


Condition or disease Intervention/treatment Phase
Acne Scars Drug: 70% glycolic acid Phase 2

Detailed Description:

Primary endpoints:

  1. ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars. Two blinded evaluators compare and rate the photograph using ECCA score.
  2. Patient Assessment Based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar

Secondary endpoints:

  1. Postacne hyperpigmentation index (PAHPI)

    -Each of these 3 variables --size, intensity, and number of lesions is weighted and the summation of the weighted variables gives the total PAHPI score, ranging 6 to 22.

  2. Safety Assessment (This is an ordinal scale) i. Score of redness ii. Score of swelling iii. Score of oozing/crusting iv. Post peel hyperpigmentation v. Post peel scarring vi. Assessment based on patient and doctor global assessment (global assessment from 1 - 10)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
Study Start Date : May 2014
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars Vitamin C

Arm Intervention/treatment
Single Arm
Single arm study - pre and post peel assessment
Drug: 70% glycolic acid



Primary Outcome Measures :
  1. Efficacy Assessment [ Time Frame: 3 months ]
    1. ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars

      • V-shaped atrophic scars with diameter <2 mm: 15
      • U-shaped atrophic scars with a diameter of 2-4 mm: 20
      • M-shaped atrophic scars with diameter >4 mm: 25
      • Superficial elastolysis: 30
      • Hypertrophic scars with a <2-year duration: 40
      • Hypertrophic scars of >2-year duration: 50 A semi-quantitative scoring of number of each scar will be performed
      • No scars: 0
      • Less than five scars: 1
      • Between five and 20 scars: 2
      • More than 20 scars: 3
    2. Patient Assessment Based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar

    Secondary endpoints

    1) Postacne hyperpigmentation index (PAHPI)


  2. Safety Assessment [ Time Frame: 3 months ]
    ) Safety Assessment (This is also an ordinal scale) i. Score of redness ii. Score of swelling iii. Score of oozing/crusting iv. Post peel hyperpigmentation v. Post peel scarring



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Atrophic scars
  2. Skin type I to IV

Exclusion Criteria:

  1. Pregnancy, breastfeeding
  2. Active dermatitis (on the face), rosacea, allergic rhinitis, active herpes simplex
  3. Known hypersensitivity
  4. Previous keloids
  5. Laser ablative procedures within the last month
  6. Chemical peels within the last 6 months
  7. Used oral retinoids in the past 6 months
  8. Used topical retinoids in the past one week
  9. Used scrub, AHA, skin irritant for the past 24h
  10. Presence of facial warts or fungal infections
  11. Photoallergies
  12. Prior poor reaction to a chemical peel
  13. Radiotherapy
  14. Skin type V and VI
  15. Patients with predominantly ice pick and boxcar scars

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126657


Contacts
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Contact: Sam SY Yang, Dr 85333992 samsyyang@gmail.com

Locations
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Singapore
National University Hospital Not yet recruiting
Singapore, Singapore, 119074
Contact: Sam Yang, Dr    85333992    samsyyang@gmail.com   
Sponsors and Collaborators
National University Hospital, Singapore

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02126657     History of Changes
Other Study ID Numbers: 2013/01230
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014
Keywords provided by National University Hospital, Singapore:
Acne scars
70% Glycolic acid peel
Additional relevant MeSH terms:
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Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes
Ascorbic Acid
Glycolic acid
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Keratolytic Agents
Dermatologic Agents