Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 19 of 83 for:    acne AND Acne Scars

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE April 28, 2014
First Posted Date  ICMJE April 30, 2014
Last Update Posted Date April 30, 2014
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2014)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars
Official Title  ICMJE 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
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.

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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Scars
Intervention  ICMJE Drug: 70% glycolic acid
Study Arms  ICMJE Single Arm
Single arm study - pre and post peel assessment
Intervention: Drug: 70% glycolic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 28, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02126657
Other Study ID Numbers  ICMJE 2013/01230
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National University Hospital, Singapore
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP