AlopeciaPhase 1NCT03662854
Safety and Tolerability of Hair Stimulating Complex (HSC) in Female Pattern Hair Loss
A Phase 1 study testing Hair Stimulating Complex (HSC) and Phosphate Buffered Saline in people with Alopecia, run by Histogen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alopecia
- What is being tested?
- Hair Stimulating Complex (HSC) and Phosphate Buffered Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 21 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
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- Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- Intrauterine coil
- Bilateral tubal ligation
- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
- Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with non-vasectomized).
- -
Who cannot join
- 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).
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- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: 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.
Read the 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
- Being tested
- Hair Stimulating Complex (HSC), Phosphate Buffered Saline
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair Stimulating Complex (HSC)Biological
Patients will receive 2 mL of HSC separated by 6 weeks (total of 4 mL of HSC)
Phosphate Buffered SalineOther
Patients will receive 2 mL of Phosphate Buffered Saline separated by 6 weeks (total of 4 mL of Phosphate Buffered Saline)
| Study group | Role | What they receive |
|---|---|---|
| Hair Stimulating Complex | Experimental | Hair Stimulating Complex (HSC) is derivative of hypoxia-induced multipotent cell conditioned media enriched for certain key growth factors Receives: Biological: Hair Stimulating Complex (HSC) |
| Phosphate Buffered Saline | Placebo comparator | Phosphate Buffered Saline Receives: Other: Phosphate Buffered Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events due to HSC
Safety and tolerability of HSC by comparing adverse events to baseline
Measured: Continuous for 22 weeks after first dose
Secondary outcomes (1)
Investigator Assessments of Global Photographs compared to baseline
Investigator Assessments of Global Photographs compared to baseline
Measured: Day 1, Week 18 and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start2 Jul 2018
- Primary completion21 Jan 2019
- Study completion21 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Histogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662854
- Sponsor's protocol ID
- 16-HIS002-US
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 21 Feb 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03662854
- Acronym / sponsor ID
- 16-HIS002-US
- Conditions
- Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- HistogenIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2021 (estimated)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Hair Stimulating Complex | Experimental | Biological: Hair Stimulating Complex (HSC)Hair Stimulating Complex (HSC) is derivative of hypoxia-induced multipotent cell conditioned media enriched for certain key growth factors |
| Phosphate Buffered Saline | Placebo comparator | Other: Phosphate Buffered SalinePhosphate Buffered Saline |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair Stimulating Complex (HSC)Patients will receive 2 mL of HSC separated by 6 weeks (total of 4 mL of HSC) | Biological | Hair Stimulating Complex |
| Phosphate Buffered SalinePatients will receive 2 mL of Phosphate Buffered Saline separated by 6 weeks (total of 4 mL of Phosphate Buffered Saline) | Other | Phosphate Buffered Saline |
Primary outcome
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
1 secondary outcome
Investigator Assessments of Global Photographs compared to baseline
Time frame: Day 1, Week 18 and 22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hair Stimulating Complex (HSC) and Phosphate Buffered Saline in people with Alopecia, run by Histogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events due to HSC (time frame: Continuous for 22 weeks after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.