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

NCT03662854 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-02-21

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Histogen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2019-01-21
Completion
2021-01-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03662854 on ClinicalTrials.gov