- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01501617
Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia (HSC Phase I/II)
January 13, 2012 updated by: Histogen
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 2
- 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
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Manila
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Pasig City, Manila, Philippines
- The Medical City
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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
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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)
- 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.
Exclusion Criteria:
- 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.
- 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.
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
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: HSC- Hair Stimulating Complex
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.
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Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6.
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Placebo Comparator: Dulbecco's Modified Eagle Medium, DMEM
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.
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Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Clinically significant change from screening visit to Week 12
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Non-vellus hair counts
Time Frame: Change from Baseline to week 12 in treatment areas
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Change from Baseline to week 12 in treatment areas
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hair Thickness Density
Time Frame: Change from Baseline to week 48 in treatment areas
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Change from Baseline to week 48 in treatment areas
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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
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Clinically significant change from Screening visit to Week 48
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Theresa Marie Reyes-Cacas, MD, The Medical City
- Principal Investigator: Julieta P. Arambulo, MD, The Medical City
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
December 1, 2011
Primary Completion (Anticipated)
June 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
December 22, 2011
First Submitted That Met QC Criteria
December 27, 2011
First Posted (Estimate)
December 29, 2011
Study Record Updates
Last Update Posted (Estimate)
January 18, 2012
Last Update Submitted That Met QC Criteria
January 13, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-HIS006-PH
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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