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

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02126644
• Other study ID #: 2013/01229
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 28, 2014
• Last updated: April 28, 2014
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: April 2014
• Source: National University Hospital, Singapore
• Contact: Sam SY Yang, Dr
• Phone: 85333992
• Email: samsyyang[@]gmail.com
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Photoaging

Intervention

Drug:
• 70% glycolic acid

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes