NCT03933774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 12, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

April 25, 2019

Results QC Date

February 19, 2020

Last Update Submit

August 11, 2020

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants Who Showed ≥75% Repigmentation

    change from Baseline and at 12 weeks

Study Arms (2)

Tretinoin 0.05% cream group

EXPERIMENTAL

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% creamDrug: Placebo cream

Placebo

PLACEBO COMPARATOR

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% creamDrug: Placebo cream

Interventions

Tretinoin 0.05% creamDRUG

Stieva-A Cream 0.05%, 25g, GSK

PlaceboTretinoin 0.05% cream group
Placebo creamDRUG

Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel

PlaceboTretinoin 0.05% cream group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32869680DERIVED

MeSH Terms

Conditions

Vitiligo

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Results Point of Contact

Title
Dr. Jung Min Bae
Organization
St. Vincent's Hospital
jminbae@gmail.com
82-31-881-8982

Study Officials

  • Jung Min Bae, MD, PhD

    Department of Dermatology, College of Medicine, Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Dermatology, St. Vincent's Hospital

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 1, 2019

Study Start

April 29, 2019

Primary Completion

November 19, 2019

Study Completion

November 29, 2019

Last Updated

August 18, 2020

Results First Posted

August 12, 2020

Record last verified: 2020-08

Locations

KR(1)