SCD-153 Phase 1b Clinical Study in Alopecia Areata
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Topically Applied SCD-153 in Patients With Alopecia Areata.
Recruitment Status: Recruiting participants in India.
Study Summary
This is an early-phase clinical research study evaluating an investigational product in people with Alopecia Areata.
This study is evaluating the safety, tolerability, pharmacokinetics, and efficacy of topically applied SCD-153 in patients with Alopecia Areata.
SCD-153 is to be externally applied on the scalp.
A prior Phase 1 study in healthy volunteers showed that SCD-153 was safe and well tolerated.
What is Alopecia Areata?
Alopecia Areata is an immune-mediated condition in which the body’s immune system affects hair follicles, which can result in patchy hair loss, sudden hair fall, and visible areas of baldness.
Why This Study Is Being Conducted
The purpose of this study is:
To check if SCD-153 is safe, tolerable, and effective for use in patients with Alopecia Areata, when applied repeatedly over time.
Who May Be Eligible To Participate?
During screening, the study doctor will assess the extent of scalp hair loss to confirm whether the condition severity matches what the study requires.
Individuals may be eligible if they:
- Have a confirmed clinical diagnosis of Alopecia Areata. (as assessed at screening).
- Are within the study age range: 18–55 years (male) and 18–45 years. (female).
- Are able to attend scheduled visits and follow study procedures.
- Meet additional study criteria confirmed during screening.
- Hair loss between 25 to 90 % of the scalp as assessed by the study physician.
Final eligibility will be determined by the study physician.
What Participation Involves
Participants who join the study may expect to:
Attend a screening visit to confirm eligibility.
If eligible, receive the investigational product for external application on the scalp at study visits.
Attend clinic visits for routine checks, which may include:
- General health monitoring and physical examinations.
- Scalp assessments.
- Blood tests and other standard safety evaluations.
Report any symptoms, concerns, or changes throughout the study.
Study Centers
The study is currently recruiting participants at multiple sites in India.
Dr. Krina Patel
GMERS Medical College & Civil Hospital, Sola. Dept. of Dermatology, A-block OPD building, GMERS Medical college & civil Hospital, Sola gam Road, Beside Gujarat High Court, Ahmedabad, Gujarat, 380060
For more information about the study, participating Centers, please visit CTRI
Learn More
- To learn more about SPARC and SCD-153 please visit SPARC-121 – Sparc Life
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