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

NCT03662854 | Unknown Phase 1 FDA Drug

• 1 other identifier: 16-HIS002-US
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Alopecia

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events due to HSC

  Safety and tolerability of HSC by comparing adverse events to baseline

  Continuous for 22 weeks after first dose

Secondary Outcomes (1)

• Investigator Assessments of Global Photographs compared to baseline

  Day 1, Week 18 and 22

Study Arms (2)

Hair Stimulating Complex

EXPERIMENTAL

Hair Stimulating Complex (HSC) is derivative of hypoxia-induced multipotent cell conditioned media enriched for certain key growth factors

Biological: Hair Stimulating Complex (HSC)

Phosphate Buffered Saline

PLACEBO COMPARATOR

Phosphate Buffered Saline

Other: Phosphate Buffered Saline

Interventions

Hair Stimulating Complex (HSC) BIOLOGICAL

Patients will receive 2 mL of HSC separated by 6 weeks (total of 4 mL of HSC)

Hair Stimulating Complex

Phosphate Buffered Saline OTHER

Patients will receive 2 mL of Phosphate Buffered Saline separated by 6 weeks (total of 4 mL of Phosphate Buffered Saline)

Phosphate Buffered Saline

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, 40-70 years of age.
• A healthy scalp with no cutaneous disorder.
• Good general health.
• Must fulfill the Ludwig I or II classification or Savin classification of frontal hair loss (see Appendix 1).
• Willing and able to comply with scheduled visits (6 visits in 22 weeks).
• Willing to maintain the same hair style and color during the study period.
• Subjects not already using any over-the-counter or prescription hair/scalp treatments, must be willing to refrain from starting use of any new hair/scalp products other than the provided study product for the duration of the study.
• Willingness to have blood and urine samples taken before and after each of the two treatments to evaluate overall systemic effect and also at Weeks 18 and 22. Also willing to give additional serum samples at each collection for long-term storage and immunogenicity testing by Histogen to components in HSC.
• Be able to speak and read English to the standard required to provide written informed consent and to cooperate with the study staff.
• Female subjects will be either of non-childbearing potential defined as:
• Having no uterus
• No menses for at least 12 months. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
• <!-- -->
• Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
• Intrauterine coil

You may not qualify if:

• Known sensitivity to any of the test material ingredients.
• History of keloid formation or hyperpigmentation.
• Pregnant, planning pregnancy or breastfeeding during the course of the study.
• A history of any acute or chronic illness that in the opinion of the investigators might confound the results of the study including some drugs or medications.
• Active skin diseases (e.g. Eczema, seborrheic dermatitis, psoriasis, skin cancer, sun damaged skin with actinic keratosis on scalp, excessive number and size of seborrheic keratosis, etc.).
• (Auto-) Immunological disorders such as HIV positive, alopecia areata, and systemic lupus erythematosus.
• Participation in any clinical study within one month prior to enrollment or planned participation in any clinical trial during the duration of their participation in this study.
• Treatment with an experimental or investigative drug or product within the last 3 months.
• Moderate/severe Seborrheic dermatitis (scalp).
• Damaged skin in or around test sites (including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test site).
• Use of any over-the-counter or prescription hair/scalp treatments for less than 6 months from date subject would start study, including finasteride or minoxidil.
• Discontinuation of the use of an over-the-counter or prescription hair/scalp treatments within the last 6 months
• Use of laser or light device for the scalp for purposes of hair growth within the last 6 months or any plans to use these devices during the duration of the study.
• History of hair transplantation surgery during the last 6 months.
• Currently using hair system or wig and/or unwilling to refrain from use throughout the duration of the study.

Sponsors & Collaborators

• Histogen: lead

Study Sites (1)

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled study

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: September 10, 2018
• Study Start: July 2, 2018
• Primary Completion: January 21, 2019
• Study Completion: January 21, 2021
• Last Updated: February 21, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)