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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tretinoin 0.05% cream group | Experimental | Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face after randomization, once a day every night |
|
| Placebo | Placebo Comparator | PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half side of the face once a day every night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tretinoin 0.05% cream | Drug | Stieva-A Cream 0.05%, 25g, GSK |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from Baseline and at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung Min Bae, MD, PhD | Department of Dermatology, College of Medicine, Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32869680 | Derived | 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. |
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This is a split-face trial. A single patient with paired lesions will be enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Left Tretinoin 0.05% Cream, Right Placebo | 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 |
| FG001 | Left Placebo, Right Tretinoin 0.05% Cream | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | score on a scale | at 12 weeks |
|
Any adverse effects (irritation, burning sensation, etc.) were collected at week 4, week 8, week 12.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tretinoin 0.05% Cream Group | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jung Min Bae | St. Vincent's Hospital | 82-31-881-8982 | jminbae@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2020 | Feb 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 |
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| Placebo cream | Drug | Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| L* value at baseline | L* value (Lightness, scale from 0 to 100, based on Lab color space) measured by a spectrophotometer at baseline. (Higher value means lighter color.) | Mean | Full Range | score on a scale |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | change from Baseline and at 12 weeks |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 6 |
| 25 |
| EG001 | Placebo Cream Group | 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 | 0 | 25 | 0 | 25 | 0 | 25 |
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| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |