PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

The Catholic University of Korea

Status: Completed

Conditions: Vitiligo

Treatments: Drug: Tretinoin 0.05% cream; Drug: Placebo cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03933774

VC18MESI0278

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups, including a placebo group

Tretinoin 0.05% cream group

Experimental group

Description:

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

Treatment:

Drug: Placebo cream

Drug: Tretinoin 0.05% cream

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo cream

Drug: Tretinoin 0.05% cream