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

February 20, 2019 updated by: Histogen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Cosmetic Laser Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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:

    1. Having no uterus
    2. 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:
    1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
    2. Intrauterine coil
    3. Bilateral tubal ligation
    4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
    5. Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).

    6. Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with non-vasectomized).

      -

      Exclusion Criteria:

  • 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.).
  • Routine high dosage use of anti-inflammatory medications (aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamine medications (Note that steroid nasal spray / drops and/or topical steroids administered to the eye(s) are not exclusion criteria, and that a daily dose of 81 - 325mg aspirin is also permitted).
  • (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.
  • History of malignancy, other than non-melanoma skin cancer. Any condition for which the Investigator determines that the subject could be placed under undue hazard.
  • Known allergy to rice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Hair Stimulating Complex
Hair Stimulating Complex (HSC) is derivative of hypoxia-induced multipotent cell conditioned media enriched for certain key growth factors
Biological: Hair Stimulating Complex (HSC)
Patients will receive 2 mL of HSC separated by 6 weeks (total of 4 mL of HSC)
PLACEBO_COMPARATOR: Phosphate Buffered Saline
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Adverse Events due to HSC
Time Frame: Continuous for 22 weeks after first dose
Safety and tolerability of HSC by comparing adverse events to baseline
Continuous for 22 weeks after first dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigator Assessments of Global Photographs compared to baseline
Time Frame: Day 1, Week 18 and 22
Investigator Assessments of Global Photographs compared to baseline
Day 1, Week 18 and 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Histogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 21, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-HIS002-US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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