Clinical trial NCT03933774: PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
Official title: PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Degree of Hyperpigmentation at 12 Weeks
timeFrame: at 12 weeks
Secondary outcomes:
measure: Number of Participants Who Showed ≥75% Repigmentation
timeFrame: change from Baseline and at 12 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Dermatology, College of Medicine, Catholic University of Korea
name: Jung Min Bae, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ju HJ, Kim SH, Lee JH, Kim GM, Bae JM. Efficacy and safety of tretinoin 0.05% cream to prevent hyperpigmentation during narrowband UV-B phototherapy in patients with facial vitiligo: a randomized clinical trial. J Dermatolog Treat. 2022 May;33(3):1738-1741. doi: 10.1080/09546634.2020.1817298. Epub 2020 Sep 10.