Effect of phototherapy on cellular infiltrate and cytokines in vitiligo
- Conditions
- Health Condition 1: L80- Vitiligo
- Registration Number
- CTRI/2021/04/033026
- Lead Sponsor
- Vinay K
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of non-segmental vitiligo involving 10-50% of body surface area
2.Age 12-60 years
3.Unstable disease, defined as occurrence of new lesion(s), progression of existing lesion(s) or Koebnerization.
1.Patients of segmental vitiligo and universal vitiligo
2.Any systemic treatment in the past 12 weeks
3.Contraindication to use of NBUVB phototherapy including xeroderma pigmentosa, systemic lupus erythematosus and other photo-induced or photo-aggravated dermatoses
4.Intake of phototoxic drugs
5.History of skin malignancy, premalignant skin lesions and dysplastic naevi
6.Claustrophobia
7.Hepatic and renal dysfunction
8.Immunosuppression
9.Associated connective tissue diseases including but not limited to systemic lupus erythematosus, rheumatoid arthritis
10.Pregnancy and lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of pre and post treatment skin biopsies by H and E, CD8+ T cell count, CD8+ CD45+ memory T cells, CD8+, CD69+ CD103+ TRM cells and FOXP3+ Treg cells and for growth factors endothelin 1, SCF, bFGF, alpha MSH <br/ ><br>Assessment of pre and post treatment blister fluid analysis for chemokines like CXCR3, CXCL9, CXCL10, IFN-γ, IL1βTimepoint: 48 weeks
- Secondary Outcome Measures
Name Time Method Clinical examination, Woodâ??s lamp examination and dermatoscopic evaluation of lesional skin; assessment of disease severity and activity by VASI and VIDA and whole body clinical photographyTimepoint: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks