Vitiligo
Conditions
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.
Interventions
DRUGTretinoin 0.05% cream
Stieva-A Cream 0.05%, 25g, GSK
DRUGPlacebo cream
Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel
Sponsors
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Participant flow
Recruitment details
This is a split-face trial. A single patient with paired lesions will be enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Left Tretinoin 0.05% Cream, Right Placebo 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. | 12 |
| Left Placebo, Right Tretinoin 0.05% Cream 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. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | Left Tretinoin 0.05% Cream, Right Placebo | Left Placebo, Right Tretinoin 0.05% Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 18 Participants |
| L* value at baseline | 58.5 score on a scale | 56.7 score on a scale | 57.6 score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 13 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 12 participants | 13 participants | 25 participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 6 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
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.
Time frame: at 12 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Left Tretinoin 0.05% Cream, Right Placebo | The Degree of Hyperpigmentation at 12 Weeks | Placebo side | 51.0 score on a scale |
| Left Tretinoin 0.05% Cream, Right Placebo | The Degree of Hyperpigmentation at 12 Weeks | Tretinoin side | 56.8 score on a scale |
| Left Placebo, Right Tretinoin 0.05% Cream | The Degree of Hyperpigmentation at 12 Weeks | Placebo side | 54.3 score on a scale |
| Left Placebo, Right Tretinoin 0.05% Cream | The Degree of Hyperpigmentation at 12 Weeks | Tretinoin side | 57.6 score on a scale |
Comparison: Null hypothesis: The degree of hyperpigmentation is the same between the tretinoin applied side and placebo applied side.p-value: 0.002t-test, 2 sided
Secondary
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.
Time frame: change from Baseline and at 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Left Tretinoin 0.05% Cream, Right Placebo | Number of Participants Who Showed ≥75% Repigmentation | Tretinoin side | 8 Participants |
| Left Tretinoin 0.05% Cream, Right Placebo | Number of Participants Who Showed ≥75% Repigmentation | Placebo side | 8 Participants |
| Left Placebo, Right Tretinoin 0.05% Cream | Number of Participants Who Showed ≥75% Repigmentation | Tretinoin side | 9 Participants |
| Left Placebo, Right Tretinoin 0.05% Cream | Number of Participants Who Showed ≥75% Repigmentation | Placebo side | 9 Participants |
Comparison: Null hypothesis: The number of participants who showed ≥75% repigmentation is the same between the tretinoin applied side and placebo applied side.p-value: 0.479McNemar