Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia (HSC Phase I/II)
|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
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia||Biological: Hair Stimulating Complex (HSC) Device: Dulbecco's Modified Eagle Medium, DMEM||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Clinical Effects of HSC (Hair Stimulating Complex) on Hair Growth in Androgenetic Alopecia: A Phase I/II Clinical Trial|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||December 2012|
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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501617
|The Medical City|
|Pasig City, Manila, Philippines|
|Principal Investigator:||Theresa Marie Reyes-Cacas, MD||The Medical City|
|Principal Investigator:||Julieta P. Arambulo, MD||The Medical City|