NCT03662854

Safety and Tolerability of Hair Stimulating Complex (HSC) in Female Pattern Hair Loss

Phase 1, Randomized, Double-Blind, Vehicle-Controlled Study of Safety and Tolerability of Hair Stimulating Complex (HSC) in Female Subjects With Female Pattern Hair Loss

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Histogen · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This double-blind placebo-controlled study will assess the tolerability, feasibility, and pharmacodynamics of intradermal Hair Stimulating Complex (HSC) in up to 18 of 27 women with Ludwig 1 or 2 classification or the Savin Frontal classification of hair loss. Safety measures include vital signs, dermatological examination of the scalp, pre- and post-dose blood and urine collection, as well as Investigator Global Assessments and subject self assessments throughout the 22-week study.

Detailed description

The study is a double-blind, placebo-controlled, randomized single site trial. The study is to be conducted in La Jolla, CA and is primarily designed to evaluate safety in the clinical application of injected HSC by assessing the tolerability of HSC, as well as the volume that can be delivered safely in the intradermal region of the scalp using a syringe with 31-gauge 1.75 mm length needle. The main study (18 weeks) involves the two treatment time points, collection of lab samples (blood/urine) for screening, and before and after the two treatment time points. Six of the seven total visits (including screening) in the study are conducted in the first 18 weeks. The final visit is for investigator monitoring, global photographs and final lab collection 30 days after the 18-week evaluation point. A 2 year follow up questionnaire will be sent to the patient to collect additional safety information. Additional dermatological exam of the scalp, as well as Subject and Investigator Assessments will also be assessed. The secondary goal of the study will be to explore whether an efficacy signal of the change in hair growth can be detected using an independent panel of physician's comparing global photographs taken at baseline to week 18 (and baseline to week 22), for changes.

Conditions

• Alopecia

Interventions

Type	Name	Description
BIOLOGICAL	Hair Stimulating Complex (HSC)	Patients will receive 2 mL of HSC separated by 6 weeks (total of 4 mL of HSC)
OTHER	Phosphate Buffered Saline	Patients will receive 2 mL of Phosphate Buffered Saline separated by 6 weeks (total of 4 mL of Phosphate Buffered Saline)

Timeline

• Start date: 2018-07-02
• Primary completion: 2019-01-21
• Completion: 2021-01-21
• First posted: 2018-09-10
• Last updated: 2019-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study