PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

Study Overview
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Brief Summary
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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
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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.

Official Title
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PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: Tretinoin 0.05% cream
* Drug: Placebo cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: older than 19 A patient with stable non-segmental vitiligo A patient with symmetrical vitiligo lesions on face A patient with the willingness to comply with the study protocol during the study period and capable of complying with it. A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages. Exclusion Criteria: Age: lower than 20 A pregnant or lactating patient A patient with active or spreading vitiligo A patient who cannot understand the study or who does not sign the informed consent Women of childbearing potential not using an effective method of contraception properly

Ages Eligible for Study
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Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tretinoin 0.05% cream group<br>Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face after randomization, once a day every night | Drug: Tretinoin 0.05% cream<br>* Stieva-A Cream 0.05%, 25g, GSK<br>Drug: Placebo cream<br>* Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel<br>|
| Placebo Comparator: Placebo<br>PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half side of the face once a day every night | Drug: Tretinoin 0.05% cream<br>* Stieva-A Cream 0.05%, 25g, GSK<br>Drug: Placebo cream<br>* Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change from Baseline and at 12 weeks |