A randomized controlled split-face pilot study was planned to investigate the preventive effect of tretinoin 0.05% cream on hyperpigmentation during phototherapy in patients with vitiligo.
Vitiligo is a chronic depigmentation disorder characterized by well-demarcated white macules and patches, reflecting selective melanocyte destruction. Hyperpigmentation at the treated areas is one of the limitations of phototherapy. Topical tretinoin (retinoic acid) has been well established to be effective for skin pigmentary disorders including melasma. This study aims to investigate the preventive effect of topical tretinoin on hyperpigmentation during phototherapy. A randomized controlled trial based on split-face was planned. The left/right face will be randomized to either tretinoin or placebo cream treatment groups. All lesions will be treated using phototherapy twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
25
Stieva-A Cream 0.05%, 25g, GSK
Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel
St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
The Degree of Hyperpigmentation at 12 Weeks
The degree of hyperpigmentation will be assessed as L\* value of Lab color space(L stands for lightness, scale from 0 to 100) using spectrophotometer at 12 weeks The higher score means the skin is lighter which means a better outcome.
Time frame: at 12 weeks
Number of Participants Who Showed ≥75% Repigmentation
Number of Participants who Showed ≥75% Repigmentation assessed at 12 weeks as % change from baseline degree using VESTA as a reference value.
Time frame: change from Baseline and at 12 weeks
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