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

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Brief Title

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

Official Title

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 Phase

Phase 1/Phase 2

Study Type

Interventional


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)

Secondary Outcome

 Hair Thickness Density

Condition

Androgenetic Alopecia

Intervention

Hair Stimulating Complex (HSC)

Study Arms / Comparison Groups

 HSC- Hair Stimulating Complex
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

56

Start Date

December 2011

Completion Date

December 2012

Primary Completion Date

June 2012

Eligibility 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.
      

Gender

Male

Ages

21 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Theresa Marie Reyes-Cacas, MD, , 

Location Countries

Philippines

Location Countries

Philippines

Administrative Informations


NCT ID

NCT01501617

Organization ID

11-HIS006-PH


Responsible Party

Sponsor

Study Sponsor

Histogen

Collaborators

 Gleneagles CRC Pte Ltd.

Study Sponsor

Theresa Marie Reyes-Cacas, MD, Principal Investigator, The Medical City


Verification Date

January 2012