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

NCT ID: NCT02126644

Last Updated: 2014-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-09-30

Brief 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.

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.

Conditions

Photoaging

Keywords

Photoaging; 70% glycolic acid peel

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Single arm of 10 patients - efficacy and safety assessed pre and post peel

Group Type: OTHER

70% glycolic acid

Intervention Type: DRUG

Interventions

70% glycolic acid

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Singapore, Singapore, Singapore

Countries

Singapore

Central Contacts

Sam SY Yang, Dr

Role: CONTACT

Phone: 85333992

Email: samsyyang@gmail.com

Facility Contacts

Sam Yang, Dr

Role: primary

Other Identifiers

2013/01229

Identifier Type: -

Identifier Source: org_study_id