Androgenetic AlopeciaPhase 1/2HSC Phase I/IINCT01501617
Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia
A Phase 1/2 study testing Hair Stimulating Complex (HSC) and Dulbecco's Modified Eagle Medium, DMEM in people with Androgenetic Alopecia, run by Histogen at 1 site in Philippines.
Trial summary
The purpose of this study is to evaluate the safety and efficacy in relation to dosing in the administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia). Read more about this study
- Who is it for?
- Ages 21 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Hair Stimulating Complex (HSC) and Dulbecco's Modified Eagle Medium, DMEM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 sitePhilippines
- Study dates
- Dec 2011to Dec 2012
- Phase
- Phase 1/2
- 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 21 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male, ages 21-65 years.
- A healthy scalp with no cutaneous disorder.
- Subject should be in good general health.
- Male subjects must be classified 3 Vertex, 4, 4A (if large enough), 5, 5A, or 6 under the Norwood-Hamilton Classification for Male Pattern Hair Loss (See Appendix 1).
- Subject must be Fitzpatrick Type I, II, III and IV skin pigmentation (See Appendix 2). Type IV is acceptable however Type I-III is preferable.
- Willing and able to comply with scheduled visits (Total: 7 visits in 48 weeks)
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- Willing to maintain the same hair style during the study period.
- Willing to have a total of four microscopic dot tattoos. Two tattoos per treatment site (one in the center and one on the edge) of the two target regions of the scalp at miniaturization zone.
- Willing to have 2 cm2 hairs clipped at treatment areas.
- Willing to forgo the use of scalp products, including dye, throughout the study except for study related dye.
- Willing to use a mild, a non-ionic shampoo throughout the course of the study.
Who cannot join
- History of keloid formation or hyperpigmentation.
- 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, atopic dermatitis, psoriasis, skin cancer, sun damaged skin with actinic keratosis on scalp, etc.).
- Routine high dosage use of anti-inflammatory medications (aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted). Two 81 mg or one 325 mg aspirin per day is also acceptable.
- Use of topical drugs or other cosmetics on the scalp.
- Immunological disorders such as HIV positive, alopecia areata, and systemic lupus erythematosus.
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- Participation in any clinical study within the last four weeks.
- Moderate or severe seborrheic dermatitis of scalp.
- Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test site.
- Use of OTC (over-the-counter) or prescriptive topical or hair treatments, as well as hair transplantation surgery during the last 6 months. This includes Minoxidil 2% or 5% and/or Finasteride 1mg or any 5alpha-reductase inhibitors.
- Currently using hair system or wig.
- Presence of hair transplants or scalp surgery.
- History of allergy or intolerance to lidocaine and/or epinephrine.
- Use of hair dye (not study related) during the study duration.
- Any condition for which the Investigator determines that the subject could be placed under undue risk.
- Reported history of allergy or intolerance to bovine proteins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Effects of HSC (Hair Stimulating Complex) on Hair Growth in Androgenetic Alopecia: A Phase I/II Clinical Trial
The purpose of this study is to evaluate the safety and efficacy in relation to dosing in the administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia).
Read the detailed description
HSC consists of proteins secreted by human dermal cells under proprietary culture conditions that include reduced oxygen and bioreactors. Under these conditions, the cells secrete soluble proteins that include both growth factors and soluble precursors to the deposited extracellular matrix. Several of these proteins are known to be important in the control of the hair cycle and will stimulate resting hair follicles to resume hair formation.
- Conditions
- Androgenetic Alopecia
- Being tested
- Hair Stimulating Complex (HSC), Dulbecco's Modified Eagle Medium, DMEM
- Keywords
- Hair Loss, Androgenetic Alopecia, Baldness, Male pattern baldness, Male pattern hair loss, Hair Regrowth, Alopecia, Hair growth, Regrow Hair
- 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
Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6.
Dulbecco's Modified Eagle Medium, DMEMDevice
Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6.
| Study group | Role | What they receive |
|---|---|---|
| HSC- Hair Stimulating Complex | Experimental | Hair Stimulating Complex will be injected intradermally into the scalp of the test subject at 2 timepoints (Baseline and 6 Weeks after Baseline) using sterile syringes with 30 gauge needles at a volume of 0.1 mL per injection. A total of 8 injections (about 3mm apart) will be administered into one of the the 2 randomized sites (left or right) of the subject's scalp. Six weeks after the Baseline injection, the same treatment site will receive a repeat dose (the same volume and number of injections as used in the baseline) with no crossover. Receives: Biological: Hair Stimulating Complex (HSC) |
| Dulbecco's Modified Eagle Medium, DMEM | Placebo comparator | Dulbecco's Modified Eagle Medium (DMEM) will be administered the same way as described above into treatment zone of the test subject's scalp not treated with HSC. Receives: Device: Dulbecco's Modified Eagle Medium, DMEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies)
Measured: Clinically significant change from screening visit to Week 12
Non-vellus hair counts
Measured: Change from Baseline to week 12 in treatment areas
Secondary outcomes (2)
Hair Thickness Density
Measured: Change from Baseline to week 48 in treatment areas
Local safety measures will be assessed by clinical exam of treatment areas and monitoring adverse events
Measured: Clinically significant change from Screening visit to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Histogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gleneagles CRC Pte Ltd.
- Responsible party
- Sponsor
- Investigators
- Theresa Marie Reyes-Cacas, MD, Principal investigator, The Medical CityJulieta P. Arambulo, MD, Principal investigator, The Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501617
- Sponsor's protocol ID
- 11-HIS006-PH
- Acronym
- HSC Phase I/II
- Status last verified
- Jan 2012
- First submitted
- 22 Dec 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of HSC (Hair Stimulating Complex) on Hair Growth in Androgenetic Alopecia: A Phase I/II Clinical Trial
- ClinicalTrials.gov ID
- NCT01501617
- Acronym / sponsor ID
- HSC Phase I/II / 11-HIS006-PH
- Conditions
- Androgenetic Alopecia
- Keywords
- Hair Loss, Androgenetic Alopecia, Baldness, Male pattern baldness, Male pattern hair loss, Hair Regrowth, Alopecia, Hair growth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- HistogenIndustry (pharma, biotech, devices)
- Collaborators
- Gleneagles CRC Pte Ltd.
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Dec 2011 (estimated)
- 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.
The purpose of this study is to evaluate the safety and efficacy in relation to dosing in the administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia).
Detailed description
HSC consists of proteins secreted by human dermal cells under proprietary culture conditions that include reduced oxygen and bioreactors. Under these conditions, the cells secrete soluble proteins that include both growth factors and soluble precursors to the deposited extracellular matrix. Several of these proteins are known to be important in the control of the hair cycle and will stimulate resting hair follicles to resume hair formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSC- Hair Stimulating Complex | Experimental | Biological: Hair Stimulating Complex (HSC)Hair Stimulating Complex will be injected intradermally into the scalp of the test subject at 2 timepoints (Baseline and 6 Weeks after Baseline) using sterile syringes with 30 gauge needles at a volume of 0.1 mL per injection. A total of 8 injections (about 3mm apart) will be administered into one of the the 2 randomized sites (left or right) of the subject's scalp. Six weeks after the Baseline injection, the same treatment site will receive a repeat dose (the same volume and number of injections as used in the baseline) with no crossover. |
| Dulbecco's Modified Eagle Medium, DMEM | Placebo comparator | Device: Dulbecco's Modified Eagle Medium, DMEMDulbecco's Modified Eagle Medium (DMEM) will be administered the same way as described above into treatment zone of the test subject's scalp not treated with HSC. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male, ages 21-65 years.
- A healthy scalp with no cutaneous disorder.
- Subject should be in good general health.
- Male subjects must be classified 3 Vertex, 4, 4A (if large enough), 5, 5A, or 6 under the Norwood-Hamilton Classification for Male Pattern Hair Loss (See Appendix 1).
- Subject must be Fitzpatrick Type I, II, III and IV skin pigmentation (See Appendix 2). Type IV is acceptable however Type I-III is preferable.
Key exclusion criteria (16 listed)
- History of keloid formation or hyperpigmentation.
- 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, atopic dermatitis, psoriasis, skin cancer, sun damaged skin with actinic keratosis on scalp, etc.).
- Routine high dosage use of anti-inflammatory medications (aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted). Two 81 mg or one 325 mg aspirin per day is also acceptable.
- Use of topical drugs or other cosmetics on the scalp.
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)Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6. | Biological | HSC- Hair Stimulating Complex |
| Dulbecco's Modified Eagle Medium, DMEMStudy preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6. | Device | Dulbecco's Modified Eagle Medium, DMEM |
Primary outcome
Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies)
Time frame: Clinically significant change from screening visit to Week 12
Non-vellus hair counts
Time frame: Change from Baseline to week 12 in treatment areas
2 secondary outcomes
Hair Thickness Density
Time frame: Change from Baseline to week 48 in treatment areas
Local safety measures will be assessed by clinical exam of treatment areas and monitoring adverse events
Time frame: Clinically significant change from Screening visit to Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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.
Theresa Marie Reyes-Cacas, MD principal investigator
The Medical City
Julieta P. Arambulo, MD principal investigator
The Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hair Stimulating Complex (HSC) and Dulbecco's Modified Eagle Medium, DMEM in people with Androgenetic Alopecia, run by Histogen at 1 site in Philippines.
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 11 inclusion and 16 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 18 Jan 2012. 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 Philippines. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies) (time frame: Clinically significant change from screening visit to Week 12). The study lists 2 primary outcomes in all. 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 18 Jan 2012.