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PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

Primary Purpose

Vitiligo

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tretinoin 0.05% cream
Placebo cream
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitiligo

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • St. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tretinoin 0.05% cream group

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 25, 2019
Last Updated
August 11, 2020
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03933774
Brief Title
PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
Official Title
PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
November 19, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tretinoin 0.05% cream group
Arm Type
Experimental
Arm Description
Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face after randomization, once a day every night
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half side of the face once a day every night
Intervention Type
Drug
Intervention Name(s)
Tretinoin 0.05% cream
Intervention Description
Stieva-A Cream 0.05%, 25g, GSK
Intervention Type
Drug
Intervention Name(s)
Placebo cream
Intervention Description
Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel
Primary Outcome Measure Information:
Title
The Degree of Hyperpigmentation at 12 Weeks
Description
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.
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Who Showed ≥75% Repigmentation
Description
Number of Participants who Showed ≥75% Repigmentation assessed at 12 weeks as % change from baseline degree using VESTA as a reference value.
Time Frame
change from Baseline and at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Min Bae, MD, PhD
Organizational Affiliation
Department of Dermatology, College of Medicine, Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32869680
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.
Results Reference
derived

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PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

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