PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

Sponsor
The Catholic University of Korea (Other)
Overall Status
Completed
CT.gov ID
NCT03933774
Collaborator
(none)
25
1
2
7
3.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tretinoin 0.05% cream
  • Drug: Placebo cream
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
Actual Study Start Date :
Apr 29, 2019
Actual Primary Completion Date :
Nov 19, 2019
Actual Study Completion Date :
Nov 29, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Tretinoin 0.05% cream
Stieva-A Cream 0.05%, 25g, GSK

Drug: Placebo cream
Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel

Placebo Comparator: Placebo

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% cream
Stieva-A Cream 0.05%, 25g, GSK

Drug: Placebo cream
Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel

Outcome Measures

Primary Outcome Measures

  1. The Degree of Hyperpigmentation at 12 Weeks [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

  1. Number of Participants Who Showed ≥75% Repigmentation [change from Baseline and at 12 weeks]

    Number of Participants who Showed ≥75% Repigmentation assessed at 12 weeks as % change from baseline degree using VESTA as a reference value.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Vincent's Hospital Suwon Gyeonggi-do Korea, Republic of 16247

Sponsors and Collaborators

  • The Catholic University of Korea

Investigators

  • Principal Investigator: Jung Min Bae, MD, PhD, Department of Dermatology, College of Medicine, Catholic University of Korea

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jung Min Bae, Department of Dermatology, St. Vincent's Hospital, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT03933774
Other Study ID Numbers:
  • VC18MESI0278
First Posted:
May 1, 2019
Last Update Posted:
Aug 18, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details This is a split-face trial. A single patient with paired lesions will be enrolled.
Pre-assignment Detail
Arm/Group Title Left Tretinoin 0.05% Cream, Right Placebo Left Placebo, Right Tretinoin 0.05% Cream
Arm/Group Description Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) on the left side of the face, moisturizer cream (Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel) on the right side of the face for 1 month, applied once a day every night Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) on the right side of the face, moisturizer cream (Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel) on the left side of the face for 1 month, applied once a day every night
Period Title: Overall Study
STARTED 12 13
COMPLETED 10 11
NOT COMPLETED 2 2

Baseline Characteristics

Arm/Group Title Left Tretinoin 0.05% Cream, Right Placebo Left Placebo, Right Tretinoin 0.05% Cream Total
Arm/Group Description The left/right sides of the face were randomly allocated to receive either topical tretinoin 0.05% (w/v) cream or moisturizer twice daily. Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) was applied on the half side of the face of the patients for 1 month, once a day every night. The left/right sides of the face were randomly allocated to receive either topical tretinoin 0.05% (w/v) cream or moisturizer twice daily. Placebo cream (Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel) was applied on the other half side of the face of the patients for 1 month, once a day every night. Total of all reporting groups
Overall Participants 12 13 25
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
8
66.7%
10
76.9%
18
72%
>=65 years
4
33.3%
3
23.1%
7
28%
Sex: Female, Male (Count of Participants)
Female
7
58.3%
4
30.8%
11
44%
Male
5
41.7%
9
69.2%
14
56%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
12
100%
13
100%
25
100%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
White
0
0%
0
0%
0
0%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
South Korea
12
100%
13
100%
25
100%
L* value at baseline (score on a scale) [Mean (Full Range) ]
Mean (Full Range) [score on a scale]
58.5
56.7
57.6

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Left Tretinoin 0.05% Cream, Right Placebo Left Placebo, Right Tretinoin 0.05% Cream
Arm/Group Description Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the left side, placebo cream on the right side of the face applied once a day every night Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the right side, placebo cream on the left side of the face applied once a day every night
Measure Participants 10 11
Tretinoin side
56.8
57.6
Placebo side
51.0
54.3
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Left Tretinoin 0.05% Cream, Right Placebo, Left Placebo, Right Tretinoin 0.05% Cream
Comments Null hypothesis: The degree of hyperpigmentation is the same between the tretinoin applied side and placebo applied side.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments P value < 0.05 was considered significant.
Method t-test, 2 sided
Comments
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Left Tretinoin 0.05% Cream, Right Placebo Left Placebo, Right Tretinoin 0.05% Cream
Arm/Group Description Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the left side, placebo cream on the right side of the face applied once a day every night Tretinoin 0.05% cream (Stieva-A Cream 0.05%, 25g, GSK) applied on the right side, placebo cream on the left side of the face applied once a day every night
Measure Participants 10 11
Tretinoin side
8
66.7%
9
69.2%
Placebo side
8
66.7%
9
69.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Left Tretinoin 0.05% Cream, Right Placebo, Left Placebo, Right Tretinoin 0.05% Cream
Comments Null hypothesis: The number of participants who showed ≥75% repigmentation is the same between the tretinoin applied side and placebo applied side.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.479
Comments P value < 0.05 was considered significant.
Method McNemar
Comments

Adverse Events

Time Frame Any adverse effects (irritation, burning sensation, etc.) were collected at week 4, week 8, week 12.
Adverse Event Reporting Description
Arm/Group Title Tretinoin 0.05% Cream Group Placebo Cream Group
Arm/Group Description Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face once a day every night Tretinoin 0.05% cream: Stieva-A Cream 0.05%, 25g, GSK PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half of the face once a day every night Placebo cream: Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel
All Cause Mortality
Tretinoin 0.05% Cream Group Placebo Cream Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/25 (0%) 0/25 (0%)
Serious Adverse Events
Tretinoin 0.05% Cream Group Placebo Cream Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/25 (0%) 0/25 (0%)
Other (Not Including Serious) Adverse Events
Tretinoin 0.05% Cream Group Placebo Cream Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 6/25 (24%) 0/25 (0%)
Skin and subcutaneous tissue disorders
Irritation 6/25 (24%) 0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Jung Min Bae
Organization St. Vincent's Hospital
Phone 82-31-881-8982
Email jminbae@gmail.com
Responsible Party:
Jung Min Bae, Department of Dermatology, St. Vincent's Hospital, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT03933774
Other Study ID Numbers:
  • VC18MESI0278
First Posted:
May 1, 2019
Last Update Posted:
Aug 18, 2020
Last Verified:
Aug 1, 2020