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

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ClinicalTrials.gov Identifier: NCT01501617
Recruitment Status : Unknown
Verified January 2012 by Histogen.
Recruitment status was:  Active, not recruiting
First Posted : December 29, 2011
Last Update Posted : January 18, 2012
Gleneagles CRC Pte Ltd.
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE December 22, 2011
First Posted Date  ICMJE December 29, 2011
Last Update Posted Date January 18, 2012
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia
Official Title  ICMJE The Clinical Effects of HSC (Hair Stimulating Complex) on Hair Growth in Androgenetic Alopecia: A Phase I/II Clinical Trial
Brief 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • Biological: Hair Stimulating Complex (HSC)
    Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6.
  • Device: Dulbecco's Modified Eagle Medium, DMEM
    Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Hair Stimulating Complex (HSC)
  • 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.
    Intervention: Device: Dulbecco's Modified Eagle Medium, DMEM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 27, 2011)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01501617
Other Study ID Numbers  ICMJE 11-HIS006-PH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Histogen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Histogen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Gleneagles CRC Pte Ltd.
Investigators  ICMJE
Principal Investigator: Theresa Marie Reyes-Cacas, MD The Medical City
Principal Investigator: Julieta P. Arambulo, MD The Medical City
PRS Account Histogen
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP