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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

Clinicaltrials.gov identifier NCT03933774

Recruitment Status Completed

First Posted May 1, 2019

Result First Posted August 12, 2020

Last update posted August 18, 2020

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:Vitiligo
  • Intervention/Treatment: Drug: Tretinoin 0.05% cream
    Drug: Placebo cream
  • Phase: 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: April 2019
  • Actual Primary Completion Date: November 2019
  • Actual Study Completion Date: November 2019
Arms and interventions
Arm Intervention/treatment
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
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
Outcome Measures
  • Primary Outcome Measures: 1. The Degree of Hyperpigmentation at 12 Weeks [ Time Frame: 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 [ Time Frame: 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
  • Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts
Locations

Korea, Republic of, Gyeonggi-do
St. Vincent's Hospital
Suwon

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

More Information
  • Responsible Party: The Catholic University of Korea
  • ClinicalTrials.gov Identifier: NCT03933774 History of Changes
  • Other Study ID Numbers: VC18MESI0278
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: August 18, 2020
  • Last Verified: August 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Vitiligo Hyperpigmentation
  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Parallel Assignment;Masking: Single;Primary Purpose: Prevention
  • Condition: Vitiligo
  • Interventions : Drug: Tretinoin 0.05% cream
    Drug: Placebo cream
  • Enrollment: 25
Participant flow
Recruitment Details This is a split-face trial. A single patient with paired lesions will be enrolled.
Pre-assignment Details
Arm/Group title Left Placebo, Right Tretinoin 0.05% Cream Left Tretinoin 0.05% Cream, Right Placebo
Arm/Group Description 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 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
Period Title: Overall Study
Started 13 12
Completed 11 10
Not Completed 2 2
Reason Not Completed
Baseline Characteristics
Arm/Group title TotalLeft Placebo, Right Tretinoin 0.05% CreamLeft Tretinoin 0.05% Cream, Right Placebo
Arm/Group Description Total of all reporting groupsThe 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.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.
Overall Number of Baseline Participants 251312
Baseline Analysis Population Description [Not Specified]
Region of Enrollment Measure Type: Number Unit of Measure: Participants Number Analyzed 25 Participants13 Participants12 Participants
Outcome Measures
1. PrimaryOutcome
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 Placebo, Right Tretinoin 0.05% CreamLeft Tretinoin 0.05% Cream, Right Placebo
Arm/Group Description 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 nightTretinoin 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
Overall Number of Participants Analyzed 1110
Measure Type: Mean (Full Range)
Unit of Measure: score on a scale
Placebo side 54.3
(45.0 to 62.0)
51.0
(46.0 to 60.0)
Tretinoin side 57.6
(52.0 to 63.0)
56.8
(49.0 to 62.0)
Statistical Analysis Overview Comparison Group Selection The Degree of Hyperpigmentation at 12 Weeks
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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P value < 0.05 was considered significant.
Method t-test, 2 sided
Comments
2. SecondaryOutcome
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 Placebo, Right Tretinoin 0.05% CreamLeft Tretinoin 0.05% Cream, Right Placebo
Arm/Group Description 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 nightTretinoin 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
Overall Number of Participants Analyzed 1110
Measure Type: Count of Participants
Unit of Measure: Participants
Placebo side 9
8
Tretinoin side 9
8
Statistical Analysis Overview Comparison Group Selection The Degree of Hyperpigmentation at 12 Weeks, Number of Participants Who Showed ≥75% Repigmentation
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 [Not Specified]
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 [Not Specified]
 
Arm/Group Title Placebo Cream GroupTretinoin 0.05% Cream Group
Arm/Group Description 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, StiefelTretinoin 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
All-Cause Mortality
  Tretinoin 0.05% Cream Group Placebo Cream Group
Affected at Risk (%) Affected at Risk (%)
Total 0/25 (0.00%) 0/25 (0.00%)
Total
Total, all-cause mortality 0 /25 (0.00%) 0 /25 (0.00%)
Serious Adverse Events
  Tretinoin 0.05% Cream Group Placebo Cream Group
Affected at Risk (%) Affected at Risk (%)
Total 0/25 (0.00%) 0/25 (0.00%)
Total
Total, serious adverse events 0 /25 (0.00%) 0 /25 (0.00%)
Show Other (Not Including Serious) Adverse Events
  Tretinoin 0.05% Cream Group Placebo Cream Group
Affected at Risk (%) Affected at Risk (%)
Total 6/25 (24.00%) 0/25 (0.00%)
Skin and subcutaneous tissue disorders
Irritation 6 /25 (24.00%) 0 /25 (0.00%)
Total
Total, other adverse events 6 /25 (24.00%) 0 /25 (0.00%)
Limitations and 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
  • ClinicalTrials.gov Identifier: NCT03933774 History of Changes
  • Other Study ID Numbers: VC18MESI0278
  • First Submitted: April 25, 2019
  • First Posted: May 1, 2019
  • Results First Submitted: February 19, 2020
  • Results First Posted: August 12, 2020
  • Last Update Posted: August 18, 2020