PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2019-11-29

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.

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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.

Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tretinoin 0.05% cream group

Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face after randomization, once a day every night

Group Type EXPERIMENTAL

Tretinoin 0.05% cream

Intervention Type DRUG

Stieva-A Cream 0.05%, 25g, GSK

Placebo cream

Intervention Type DRUG

Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel

Placebo

PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half side of the face once a day every night

Group Type PLACEBO_COMPARATOR

Tretinoin 0.05% cream

Intervention Type DRUG

Stieva-A Cream 0.05%, 25g, GSK

Placebo cream

Intervention Type DRUG

Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel

Interventions

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Tretinoin 0.05% cream

Stieva-A Cream 0.05%, 25g, GSK

Intervention Type DRUG

Placebo cream

Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes