| CTRI Number |
CTRI/2023/03/050766 [Registered on: 16/03/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of light therapy on bone strength and blood vitamin D levels in vitiligo patients |
|
Scientific Title of Study
|
Effect of Narrow Band Ultraviolet-B treatment on bone mineral density and vitamin D levels in vitiligo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keshavamurthy Vinay |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute Of Medical Education And Research, Chandigarh |
| Address |
Room no 8
Level 2
Block F
Department Of Dermatology
Post Graduate Institute Of Medical Education And Research
Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
vinay.keshavmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Keshavamurthy Vinay |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute Of Medical Education And Research, Chandigarh |
| Address |
Room no 8
Level 2
Block F
Department Of Dermatology
Post Graduate Institute Of Medical Education And Research
Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
vinay.keshavmurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Keshavamurthy Vinay |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute Of Medical Education And Research, Chandigarh |
| Address |
Room no 8
Level 2
Block F
Department Of Dermatology
Post Graduate Institute Of Medical Education And Research
Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
vinay.keshavmurthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER Sector 12 Chandigarh |
|
|
Primary Sponsor
|
| Name |
Keshavamurthy Vinay |
| Address |
Associate Professor
Room no 8 Level 2 Block F Nehru Hospital PGIMER Sector 12 Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vinay Keshavamurthy |
New OPD PGIMER Chandigarh |
Department of Dermatology, Room 5006, Level 5, Block C
New OPD, PGIMER Chandigarh
Chandigarh
CHANDIGARH |
0172-2756564
vinay.keshavmurthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Narrow Band UVB |
The study patients will be treated with whole body NBUVB phototherapy unit, administered thrice a week on alternate days. An initial dose of 200 mJ/cm2 will be administered and increased by 20% at each visit up to a maximum of 1400 mJ/cm2 subject to each patient’s tolerance. The end point for considering patients tolerance for dose escalation is minimal perceptible erythema lasting less than 24 hours. Dose increments will not be done any further when there is asymptomatic fixed minimal erythema at 48 hrs (1+). In patients with symptomatic erythema or asymptomatic bright red erythema at 48 hours, the subsequent dose of phototherapy will be skipped (2+) until the affected area becomes light pink. Treatment will then be resumed at the previous dose used. In patients developing severe phototoxic reaction including blisters (3+), phototherapy will be withheld until complete recovery and restarted at the last tolerated dose. In patients who miss more than 2 consecutive appointments, the dose of NBUVB will be reduced by 25%/week. During each treatment, genital area will be shielded with clothing and eyes protected by UV blocking goggles. If lesions are present on eyelids, patients would be asked to keep eyes closed during treatment without goggles. Patients will be advised to apply sunscreen on exposed areas and to avoid sun- exposure subsequent to phototherapy session for 24 hours.
NBUVB phototherapy will be administered for at least 16 weeks (48 sessions) in all patients. Patients who fail to develop any signs of repigmentation at the end of 16 weeks will be considered as primary non-responders and phototherapy will be discontinued. In responding patients, phototherapy will be continued until complete repigmentation or 24 weeks (144 sessions) whichever is earlier. Subsequently, the phototherapy sessions will be reduced to twice weekly sessions for one month, followed by once a week maintenance phototherapy for one more month before completely discontinuing phototherapy. Patients are considered compliant to their phototherapy, if they have attended at least 90% of their scheduled phototherapy visits.
|
| Comparator Agent |
Oral non-steroidal disease stabilizing agent |
Patients in group B will serve as an active control and will receive an oral non-steroidal disease stabilizing agent (e.g., azathioprine, cyclosporine, methotrexate, tofacitinib, etc.) according to body weight. Appropriate baseline and serial clinical and laboratory evaluation shall be undertaken. Patients in whom arrest of disease progression (absence of new lesions and non-progression of pre-existing lesions) is not attained after 16 weeks of therapy will be declared non-responders and will be shifted to alternative therapies. Treatment shall be continued for 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
4. Should have received corticosteroids in any dose for >3 months
|
|
| ExclusionCriteria |
| Details |
1. Patients of segmental vitiligo and universal vitiligo
2. Contraindication to use of NBUVB phototherapy including xeroderma pigmentosa, systemic lupus erythematosus and other photo-induced or photo-aggravated dermatoses
3. Intake of phototoxic drugs
4. History of skin malignancy, premalignant skin lesions and dysplastic naevi
5. Claustrophobia
6. Hepatic and renal dysfunction
7. Immunosuppression
8. Associated connective tissue diseases including but not limited to systemic lupus erythematosus, rheumatoid arthritis
9. Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Measurement of bone mineral density using dual-energy X-ray absorptiometry (DEXA) at baseline and after 24 weeks.
2. Measurement of serum vitamin D levels at baseline and after 24 weeks |
Baseline
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Whole body narrow band-ultraviolet B (NB-UVB) phototherapy is widely used to treat extensive and spreading vitiligo. NB-UVB phototherapy is known to cause disease stabilization as well as re-pigmentation. Several other benefits of NB-UVB, including reduction in risk of cerebrovascular and cardiovascular adverse events have been observed. Indirect impact of NB-UVB on bone mineral density has been reported in terms of reduction in risk of osteoporotic fractures. However, direct impact of NB-UVB on bone health has not been assessed before. The present study, we aim to assess the effect of Narrow Band Ultraviolet-B treatment on bone mineral density and vitamin D levels in vitiligo patients who have previously received corticosteroid therapy. Further, as corticosteroid-induced osteopenia/osteoporosis tends to improve on cessation of steroid therapy, a control group in which patient will receive a non-steroidal disease stabilising agent (e.g., azathioprine, cyclosporine, methotrexate, etc.) with no known impact on bone mineral density will also be recruited. |
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