Combined Therapy With Narrow-Band Ultraviolet B Phototherapy and Apremilast for the Treatment of Vitiligo
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|ClinicalTrials.gov Identifier: NCT03123016|
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : August 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Drug: Apremilast Procedure: NB-UVB phototherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Enrolled subjects will be randomized to treatment with narrowband UVB two to three times weekly to one half of their body for a total of 16 weeks, while the contralateral side of the body is covered by a special garment to prevent any UVB treatment|
|Masking:||None (Open Label)|
|Official Title:||A Split Body Study of the Effects of Combined Therapy With Narrow-Band Ultraviolet B Phototherapy and Apremilast for the Treatment of Vitiligo|
|Actual Study Start Date :||April 14, 2017|
|Actual Primary Completion Date :||August 5, 2019|
|Actual Study Completion Date :||August 5, 2019|
Experimental: Vitiligo with Apremilast and NB-UVB phototherapy
Each participant will be compared with one side of the body to the other side
Apremilast 30 mg orally, twice daily. (oral tablet)
Procedure: NB-UVB phototherapy
treatment with narrowband UVB two to three times weekly to one half of their body for a total of 16 weeks
- Change in proportion of responders to treatment from Week 16 to Week 32 [ Time Frame: Week 16 and Week 32 ]The proportion of responders to apremilast plus concomitant NB-UVB at week 32 compared to the proportion of responders to NB-UVB phototherapy at week 16.
- Body Surface Area (BSA) [ Time Frame: Week 32 and Week 48 ]One hand unit, which encompasses the palm plus the volar surface of all the digits, is approximately 1% of the total body surface area and is used as a guide to estimate each body region.
- VASI score - Vitiligo Area and Severity Index (VASI) [ Time Frame: Week 32 and Week 48 ]One hand unit, which encompasses the palm plus the volar surface of all the digits, is approximately 1% of the total body surface area and is used as a guide to estimate the baseline percentage of vitiligo involvement in each body region. The body is divided into five separate and mutually exclusive regions: hands, upper extremities (excluding hands), trunk, lower extremities (excluding feet), and feet. The axillary region is included with the upper extremities while the buttocks and inguinal areas are included with the lower extremities. The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation are present.
- VETF score - Vitiligo European Task Force (VETF) score [ Time Frame: Up to 64 weeks ]
The VETF is a validated scoring system that assesses 3 dimensions of the disease (extent, staging, and spreading/progression). (1) the extent of vitiligo will be estimated as the percentage of vitiligo involvement of 5 body sites. (2) Stage of vitiligo will be assessed as 0 (normal pigmentation), 1 (incomplete depigmentation), 2 (complete depigmentation), 3 (partial hair whitening [<30%]), and 4 (complete hair whitening). (3) Spreading of vitiligo will be scored as 0 (stable disease), −1 (observed ongoing subclinical repigmentation), and +1 (additional patches in a given area or observed ongoing subclinical depigmentation). The VETF score calculated as follows:
VETF Extent or Staging or Spreading = Sum of all specific values for that category from all body sites (% of Area affected for Extent; 0-20 for Staging; -5 to +5 for Spreading).
- Dermatology Life Quality Index [ Time Frame: Up to 64 weeks ]The DLQI is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions, and its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomized controlled trials in dermatology.
- Visual Analogue Scale (VAS) [ Time Frame: Up to 64 weeks ]The VAS is commonly used as the outcome measure in research studies. A VAS for satisfaction is a horizontal line of 100-mm long. At the beginning and at the end, there are two descriptors representing extremes of satisfaction (i.e. no satisfaction and extreme satisfaction). The patients rate their satisfaction by making a vertical mark on the 100-mm line. The measurement in millimeters is converted to the same number of points ranging from 0 to 100 points. The exact question will be "Are you satisfied with your study treatment?"
- Number of Adverse Events [ Time Frame: Up to 64 weeks ]Safety analyses will be performed on the safety population. Safety will be evaluated by tabulations of adverse events (AEs) and will be presented with descriptive statistics at each visit. AEs will be coded using the CTCAE, Common Terminology Criteria for Adverse Events, V 4.0. The CTCAE v4.0 AE terms are MedDRA's LLTs (Lowest Level Terms) which are based on their MedDRA (System Organ Class). The number and percentage of subjects experiencing an AE/SAE will be stratified by system organ class, or a preferred term, and/or severity of the adverse event, and recorded and tabulated overall.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123016
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Mark Lebwohl, MD||Icahn School of Medicine at Mount Sinai|