Pilot study of a novel treatment for androgenetic alopecia using enriched cell culture medium: clinical trials.
Androgenetic Alopecia (AA) afflicts a large part of the population and of the many treatments available today none is completely satisfactory. Testing the efficacy and safety of a novel topical treatment for AA which is based on cell culture medium supplemented with insulin, thyroxin and growth hormone (CCM). The 48 participants classified as androgenetic alopecia Type II, III or IV on the Hamilton scale, concluded a randomized, vehicle-controlled, double-blind trial of 6 months duration. Under occlusive cover the gel was self applied for at least 3 hours daily. Evaluation was based on hair counts, investigator global assessment and participants self-administered questionnaire. Cessation of hair loss was reported by most participants within 28 weeks, and further confirmed by the hair count (HC) in ~80% of participants. Moreover, as early as 4 months after the start of the treatment, a time dependent increase of up to 50% in HC was observed. The average change in HC between the two groups differed significantly (p=0.007), with values of 4.1% for control and 13.8% for CCM. Following 4 months of treatment, a time dependent increase in HC (>10%) above minimal was observed in 55% of the CCM and 25% of the control and this trend continued. At 6 months 63% of the CCM and 33% of the control group exhibited increase of HC higher than 10%. The average increase in HC in the CCM and the control groups was 17.1% and 8.9% respectively (p=0.035). Self evaluation questionnaires revealed a time dependent increase in satisfaction in the CCMusers compared to the control. While the average score at T2 was similar in CCM and control (2.7 and 2.6 respectively), the score at T6 in the CCM increased to 5.9 and decreased to -0.4 in the control (p=0.007). Global-clinical evaluation following six months treatment revealed significantly (p=0.02) more hair loss in the control group (40%) compared to the CCM (7%) treated group. CCM was found effective in treating androgenetic alopecia in men. It induced cessation of hair loss, increased rate of hair growth and appearance of new hair. No side effects were reported or observed.
Lindenbaum
E S
ES
samnella@hargray.com 2
Feitelberg
A L
AL
Tendler
M
M
Beach
D
D
Gamliel-Lazarovich
A
A
Har-Shai
Y
Y
Hirshowitz
B
B
D000287:Administration, Topical; D000328:Adult; D000505:Alopecia / Q000188:drug therapy*; D003470:Culture Media / Q000494:pharmacology; D004311:Double-Blind Method; D004338:Drug Combinations; D005782:Gels; D013006:Growth Hormone / Q000008:administration & dosage*; D006197:Hair / Q000166:cytology / Q000254:growth & development; D006801:Humans; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D009779:Occlusive Dressings; D017060:Patient Satisfaction; D010865:Pilot Projects; D013974:Thyroxine / Q000008:administration & dosage*
D003470:Culture Media; D004338:Drug Combinations; D005782:Gels; D007328:Insulin; D013006:Growth Hormone; D013974:Thyroxine