Clinical trial NCT01501617: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Androgenetic Alopecia
Keywords: Hair Loss
Androgenetic Alopecia
Baldness
Male pattern baldness
Male pattern hair loss
Hair Regrowth
Alopecia
Hair growth
Regrow Hair
Lead sponsor: Histogen
Sponsor class: INDUSTRY
Collaborators: name: Gleneagles CRC Pte Ltd.
First posted: 2011-12-29
Enrollment: 56
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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)
timeFrame: Clinically significant change from screening visit to Week 12
measure: Non-vellus hair counts
timeFrame: Change from Baseline to week 12 in treatment areas
Secondary outcomes:
measure: Hair Thickness Density
timeFrame: Change from Baseline to week 48 in treatment areas
measure: Local safety measures will be assessed by clinical exam of treatment areas and monitoring adverse events
timeFrame: Clinically significant change from Screening visit to Week 48
Other outcomes:
Locations:
city: Pasig City
country: Philippines
facility: The Medical City
state: Manila
Study officials:
affiliation: The Medical City
name: Theresa Marie Reyes-Cacas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Medical City
name: Julieta P. Arambulo, MD
role: PRINCIPAL_INVESTIGATOR
References: