Health Condition 1: L639- Alopecia areata, unspecified
Conditions
Interventions
Intervention1: SCD-153 (active drug): Frequency of Application: once-daily or alternate day or twice-daily
Route of Administration: Topical Application
Duration of Treatment: Approximately 03-06 month
Sponsors
Sun Pharma Advanced Research Company Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males between 18-55 years (both inclusive) and adult non-pregnant, non-lactating females between 18-45 years of age (both inclusive) at Screening. 2. Clinical diagnosis of Alopecia Areata. 3. Willingness to provide written informed consent and comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. History or presence of clinically relevant, systemic disease. 2. Laboratory abnormalities at Screening that is assessed as clinically significant by the investigator. 3. History of allergy to investigational medicinal product or excipients and any history of and/or concurrent condition of serious hypersensitivity (e.g., anaphylaxis) to drugs, foods, or other allergens. 4. Participation in an investigational drug study in which the administration of the investigational drug was within 30 days. 5. Active inflammatory skin disease other than AA or active trauma on the scalp that could potentially interfere with assessments. 6. History or presence of hair transplants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of unacceptable toxicityTimepoint: Week 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse eventsTimepoint: Week 29;Incidence of local skin reactionsTimepoint: Week 29 | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar
Sun Pharma Advanced Research Limited
Outcome results
None listed