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

NCT01501617 | Unknown Phase 1 DMC

• 1 other identifier: 11-HIS006-PH
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Androgenetic Alopecia

Keywords

Hair Loss; Androgenetic Alopecia; Baldness; Male pattern baldness; Male pattern hair loss; Hair Regrowth; Alopecia; Hair growth; Regrow Hair

Outcome Measures

Primary Outcomes (2)

• 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)

  Clinically significant change from screening visit to Week 12

• Non-vellus hair counts

  Change from Baseline to week 12 in treatment areas

Secondary Outcomes (2)

• Hair Thickness Density

  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

  Clinically significant change from Screening visit to Week 48

Study Arms (2)

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.

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.

Device: Dulbecco's Modified Eagle Medium, DMEM

Interventions

Hair Stimulating Complex (HSC) BIOLOGICAL

Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6.

HSC- Hair Stimulating Complex

Dulbecco's Modified Eagle Medium, DMEM DEVICE

Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6.

Dulbecco's Modified Eagle Medium, DMEM

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Histogen: lead
• Gleneagles CRC Pte Ltd.: collaborator

Study Sites (1)

The Medical City

Pasig, Manila, Philippines

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Theresa Marie Reyes-Cacas, MD

  The Medical City

  PRINCIPAL INVESTIGATOR

• Julieta P. Arambulo, MD

  The Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 29, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

PH (1)