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Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia (HSC Phase I/II)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gleneagles CRC Pte Ltd.
Information provided by (Responsible Party):
Histogen
ClinicalTrials.gov Identifier:
NCT01501617
First received: December 22, 2011
Last updated: January 13, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Androgenetic Alopecia
 Biological: Hair Stimulating Complex (HSC)
Device: Dulbecco's Modified Eagle Medium, DMEM
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Effects of HSC (Hair Stimulating Complex) on Hair Growth in Androgenetic Alopecia: A Phase I/II Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Histogen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Non-vellus hair counts [ Time Frame: Change from Baseline to week 12 in treatment areas ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hair Thickness Density [ Time Frame: Change from Baseline to week 48 in treatment areas ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Biological: Hair Stimulating Complex (HSC)
Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6.
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.
 Device: Dulbecco's Modified Eagle Medium, DMEM
Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male, ages 21-65 years.
  2. A healthy scalp with no cutaneous disorder.
  3. Subject should be in good general health.
  4. 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).
  5. 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.
  6. Willing and able to comply with scheduled visits (Total: 7 visits in 48 weeks)
  7. Willing to maintain the same hair style during the study period.
  8. 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.
  9. Willing to have 2 cm2 hairs clipped at treatment areas.
  10. Willing to forgo the use of scalp products, including dye, throughout the study except for study related dye.
  11. Willing to use a mild, a non-ionic shampoo throughout the course of the study.

Exclusion Criteria:

  1. History of keloid formation or hyperpigmentation.
  2. 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.
  3. Active skin diseases (e.g. eczema, atopic dermatitis, psoriasis, skin cancer, sun damaged skin with actinic keratosis on scalp, etc.).
  4. 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.
  5. Use of topical drugs or other cosmetics on the scalp.
  6. Immunological disorders such as HIV positive, alopecia areata, and systemic lupus erythematosus.
  7. Participation in any clinical study within the last four weeks.
  8. Moderate or severe seborrheic dermatitis of scalp.
  9. Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test site.
  10. 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.
  11. Currently using hair system or wig.
  12. Presence of hair transplants or scalp surgery.
  13. History of allergy or intolerance to lidocaine and/or epinephrine.
  14. Use of hair dye (not study related) during the study duration.
  15. Any condition for which the Investigator determines that the subject could be placed under undue risk.
  16. Reported history of allergy or intolerance to bovine proteins.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501617

Locations
Philippines
The Medical City
Pasig City, Manila, Philippines
Sponsors and Collaborators
Histogen
Gleneagles CRC Pte Ltd.
Investigators
Principal Investigator: Theresa Marie Reyes-Cacas, MD The Medical City
Principal Investigator: Julieta P. Arambulo, MD The Medical City
  More Information

No publications provided

Responsible Party: Histogen
ClinicalTrials.gov Identifier: NCT01501617     History of Changes
Other Study ID Numbers: 11-HIS006-PH
Study First Received: December 22, 2011
Last Updated: January 13, 2012
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Histogen:
Hair Loss
Androgenetic Alopecia
Baldness
Male pattern baldness
Male pattern hair loss
 Hair Regrowth
Alopecia
Hair growth
Regrow Hair

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013