PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
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 |
---|---|---|
|
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
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
- 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
- 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
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.- VC18MESI0278
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
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 |
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
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 |
jminbae@gmail.com |
- VC18MESI0278