Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03270241|
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : July 18, 2018
Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients' quality of life across all degrees of involvement and severity. Phototherapy, such as Narrow band UVB (NB-UVB), is a clinically indicated treatment for skin lesions. NB-UVB treatment has been shown to promote repigmentation and normalize cellular behaviors. The investigators would like to analyze the change in protein expression and histological change in skin from NB-UVB treatment in participants with Vitiligo.
The investigators are recruiting participants with Vitiligo on the body, arms, and/or legs.
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo Dermatology/Skin - Other||Device: Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet||Not Applicable|
This is a dermatology study of the effects of short-term NB-UVB treatment, standard phototherapy for Vitiligo patients. In the study, demographics information, three ascending dose of phototherapy, and small skin biopsies will be required of the participants.
For all enrolled participants, the starting dose of NB-UVB administered will be 250 mJ/cm2, which is the standard of care for patients with Vitiligo. The dose will be increased by 10% with each treatment, as long as there are no side effects with treatment such as burning or redness/ erythema. Small skin biopsies will be collected from normal skin and from affected skin from vitiligo participants at the baseline visit and 3 days after the conclusion of treatment; up to a total of 6 biopsies will be collected from each patient. Participants will be compensated for time and effort.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants diagnosed with Vitiligo who are enrolled in the study will receive phototherapy (NB-UVB), with the starting dose of 250 mJ/cm2. The dose will be increased by 10% with each treatment. Small skin samples will be collected before and after NB-UVB treatment.|
|Masking:||None (Open Label)|
|Official Title:||Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: Phototherapy (NB-UVB)
Phototherapy (NB-UVB) will be administered for all enrolled subjects. The starting dosage will be 250 mJ/cm2. The dose will be increased by 10% with each treatment, as long as there are no side effects with treatment.
Device: Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet
This is an investigator-initiated, single-blinded, ascending dose study of NB-UVB treatment for Vitiligo in adults of 3 treatments for one week. It is designed to measure the molecular changes and re-pigmentation in affected and normal skin of participants with Vitiligo and normal skin in healthy participants.
- Molecular changes from NB-UVB therapy [ Time Frame: 2 years ]The investigators are assessing the histological and molecular changes of normal and Vitiligo-lesion skin from NB-UVB therapy. The molecular markers (in microgram/ mL) include, but not limited to, KIT receptor, stem cell factor (SCF), tumor necrosis factor-alpha (TNF-alpha), and interleukin-1 (IL-1).
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): NCT03270241
|Contact: Sooyoung Kim, M.D.||firstname.lastname@example.org|
|Contact: Rena Zuo, M.D.||410-502-7546||Rzuo2@jhmi.edu|
|United States, Maryland|
|Johns Hopkins Outpatient Center||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Sooyoung Kim, M.D. 410-502-7546 CTReP@jhmi.edu|
|Principal Investigator: Noori Kim, M.D.|
|Sub-Investigator: Anna Chien, M.D.|
|Sub-Investigator: Rena Zuo, M.D.|
|Sub-Investigator: Ginette Okoye, M.D.|