Health Condition 1: L409- Psoriasis, unspecified Health Condition 2: L80- Vitiligo
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
Eris Oaknet Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients >=06 years and 2. Treatment failure/non-responder/treatment naïve patients 3. Patients with vitiligo having 4. Patients who are willing to provide informed consent and comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Patients who are unsure of complying with the treatment protocol 2. Patients with a previous history of skin cancer 3. Patients suffering from photosensitivity disorder 4. Those who do not have a suitable place for sun exposure 5. Patients who are on immunosuppressants/immunomodulators, corticosteroids, or retinoids for other comorbidities 6. Pregnant and lactating women or those planning for pregnancy 7. Patients with lesions on scalp and private areas which cannot be exposed to sunlight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of Photofirst in the management of vitiligo 2. To evaluate the safety of Photofirst in the management of vitiligo 3. To evaluate the effectiveness of Photofirst in the management of psoriasis 4. To evaluate the safety of Photofirst in the management of psoriasisTimepoint: Primary Endpoints (Vitiligo): 1. Total -Vitiligo Area Scoring Index (T-VASI) at 12 weeks from baseline 2. Facial- Vitiligo Area Scoring Index (F-VASI) at 12 weeks from baseline 3. Assessment of local side effects reported during the treatment period Primary Endpoints (Psoriasis): 1. Psoriasis Area and Severity Index (PASI) score at 12 weeks from baseline 2. Assessment of local side effects reported during the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To further evaluate the effectiveness of Photofirst in the management of vitiligo 2. To further evaluate the effectiveness of Photofirst in the management of psoriasisTimepoint: T-VASI score at 4 weeks and 8 weeks from baseline,F-VASI at 4 weeks and 8 weeks from baseline,T-VASI-90 at 12 weeks from baseline,T-VASI-75 at 12 weeks from baseline,T-VASI-50 at 12 weeks from baseline,F-VASI-90 at 12 weeks from baseline,F-VASI-75 at 12 weeks from baseline,F-VASI-50 at 12 weeks from baseline PASI score at 4 weeks and 8 weeks from baseline ,PASI-90 at 12 weeks from baseline,PASI-75 at 12 weeks from baseline,PASI-50 at 12 weeks from baseline | — |
Countries
India
Contacts
Public ContactDr Venugopal Madhusudhana
Sekhmet Technologies Pvt. Ltd
Outcome results
None listed