NCT03933774

PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Tretinoin 0.05% cream	Stieva-A Cream 0.05%, 25g, GSK
DRUG	Placebo cream	Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel

Timeline

• Start date: 2019-04-29
• Primary completion: 2019-11-19
• Completion: 2019-11-29
• First posted: 2019-05-01
• Last updated: 2020-08-18
• Results posted: 2020-08-12

Locations

1 site across 1 country: South Korea