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

Phase 2 Study of the Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Photoaging

Our study involves the evaluation of a high potency peel in its efficacy for skin rejuvenation in the treatment of photoaging. This chemical peel regime is a high potency peel 70% glycolic acid combined with vitamin C that is purported to provide a good balance between yielding results and patient safety.

AIM We aim to qualitatively evaluate its efficacy and safety profile.

Our hypothesis is that a single peel of 70% glycolic acid combined with vitamin C will result in improvement of the features of photoaging with few side effects.

Study Overview

• Status: Unknown
• Conditions: Photoaging
• Intervention / Treatment: Drug: 70% glycolic acid

Detailed Description

1. Assessment of photoaging to compare using photography A and E - for static analysis.

   For each element from ii to xi, a rating of nil (0), mild (l), moderate (2), and severe (3) for each category was made by the same evaluating physician.

   i. Physician VAS scale - assessment of wrinkles prepeel, post peel (Score 1 -10).

   ii.Fine peri-orbital wrinkles (less than 1 mm in width or depth) (FPW); iii.Course peri-orbital wrinkles (greater than 1 mm in width and depth) (CPW); iv.Upper lip wrinkles (ULW); v.Lower lip wrinkles (LLW); vi.Melasma defined as blotchy, brown, epidermal macules with indistinct margins; vii.Solar lentigines defined as dark brown macules with distinct margins measuring from 3 to 10 mm; viii.Solar keratoses defined as diffuse erythema with keratotic adherent scaling; ix.Guttate hypomelanosis defined as localized macules of absent melanin measuring from 3 to 10 mm in diameter; x.Poikiloderma defined as a symmetrical reddish-brown pigmentation of the neck, typically sparing the sub-mental area;

   The totaling of the scores of the above parameters will form a prepeel score. This will be compared against the patient's score post peel - we expect to find an improvement.

2. Safety profile assessment

   • redness, swelling, oozing, hyperpigmentation, scarring
   • each of the 5 parameters will be scored from 0 -3, none, mild, moderate, severe
   • this will serve as a safety assessment.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Photoaging Grade 2-4 (face) Skin type I - IV

Exclusion Criteria:

• Pregnancy, breast feeding Active dermatitis on the face, rosacea, allergic rhinitis, herpes Known hypersensitivity Previous Keloids Laser ablative procedures within the last one month Chemical Peels in the last 6 months Used oral retinoids in the last 6 months Used topical retinoids in the past one week Used Scrub, Alpha Hydroxy Acid, skin irritant for the past 24h Presence of facial warts, fungal infections Photoallergies Prior poor reaction to a chemical peel Radiotherapy Skin type V and VI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Single Arm; Single arm of 10 patients - efficacy and safety assessed pre and post peel	Drug: 70% glycolic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Parameters for Photoaging	i. Physician VAS scale - Score 1 -10. ii.Fine peri-orbital wrinkles iii.Course peri-orbital wrinkles; iv.Upper lip wrinkles (ULW); v.Lower lip wrinkles (LLW); vi.Melasma vii.Solar lentigines viii.Solar keratoses ix.Guttate hypomelanosis x.Poikiloderma The totaling of the scores of the above parameters will form a prepeel score. This will be compared against the patient's score post peel - we expect to find an improvement.	3 months
Safety Assessment	Safety profile assessment; redness, swelling, oozing, hyperpigmentation, scarring; each of the 5 parameters will be scored from 0 -3, none, mild, moderate, severe	3 months

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): September 1, 2014
• Study Completion (ANTICIPATED): September 1, 2014

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (ESTIMATE): April 30, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 30, 2014
• Last Update Submitted That Met QC Criteria: April 28, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Photoaging; 70% glycolic acid peel
• Additional Relevant MeSH Terms: Skin Diseases; Dermatologic Agents; Keratolytic Agents; Glycolic acid
• Other Study ID Numbers: 2013/01229