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

Study Overview
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Brief Summary
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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
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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. 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.

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

Conditions
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Photoaging

Intervention / Treatment
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* Drug: 70% glycolic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Single arm of 10 patients - efficacy and safety assessed pre and post peel | Drug: 70% glycolic acid<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photoaging, 70% glycolic acid peel