Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Alsys Life AG
Tested Services
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female participants (non-pregnant) aged 18 65 years (both inclusive). 2 Participants willing to provide written informed consent. 3 Participants committed to availability throughout the study duration. 4 Patients willing to adhere to protocol specified requirements. 5 Participants with laboratory values, if tested recently, are within normal reference ranges or deemed clinically non-significant by the physician or Principal Investigator.
Exclusion criteria
Exclusion criteria: 1. Participants who had atleast 25% of the body surface area covered by psoriasis lesions (assessed through PASI score Psoriasis Activity and Severity Index) scoring system. 2. Participants on anti-coagulant therapy, using non-immunosuppressive medication within past two months. 3. Institutionalized individuals or those unable to provide informed consent. 4. History or presence of chronic illnesses, including diabetes, hypertension, liver or kidney disorders, cardiovascular or pulmonary diseases, gastrointestinal conditions, infections, dermatological disorders, or malignancies. 5. Participants with skin lesions like actinic or lentigo or photo damaged skin. 6. History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rashes. 7. Participation in another clinical study within the last 90 days. 8. Participants who had used systemic or intralesional therapy or photo (chemo) therapy for psoriasis in the previous month. 9. Individuals with concomitant bacterial, fungal or viral skin infections. 10. Female participants with a positive pregnancy test, those who are breastfeeding, or those likely to become pregnant during the study. 11. Use of implanted or injected hormonal contraceptives within six months prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atleast 75% reduction or clinical remission of psoriasis as evidenced by PASI score, photographic images of lesions between Day 0 and Day 45.Timepoint: Day 0 and Day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| Atleast 50% remission of psoriasis as assessed through Global Evaluation by Physician and Global Evaluation by Patients between Day 0 and Day 45. Incidence, severity, and relationship of adverse events (AEs) safety endpoint. Changes in vital signs (heart rate, blood pressure, respiratory rate, and body temperature) for assessment of safety. Timepoint: Day 0 and Day 45 | — |
Countries
India
Contacts
Public ContactSravani P S L
Tested Services
Outcome results
None listed