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