Effect of Miracle Fruit ( Synsepalum dulcificum ) Seed Oil (MFSO ® ) on the Measurable Improvement of Hair Breakage in Women with Damaged Hair: A Randomized, Double-blind, Placebo-controlled, Eight-month Trial.

Background: Hair breakage is a common unrecognized form of hair loss in women most often the result of hair weathering and traumatic grooming practices. Lipids are major determinants of the physical properties of the hair. Synsepalum dulcificum seed oil (MFSO® ; Miracle Fruit Oil Co., Miami Beach, Florida), is an exotic fruit oil with physicochemical properties suited to providing a superior ability to reduce hair breakage. Objective: To assess the safety and efficacy of a hair oil containing MFSO and its effects on hair breakage rates. Methods: Healthy, long-haired women (age range: 19-63 years, mean age: 36.7 years, standard deviation: 10.77 years) with excessive hair breakage were randomized in this double-blind, placebo-controlled study to receive MFSO (n=24), vehicle (n=17), or argan oil (n=16). Measurements of hair length, hair diameter, and Hair Mass Index were performed at baseline, Month 4, and Month 8. Hair Breakage Index and the Healthy Hair Index values were calculated from the trichometer measurements, and subject self-assessment questionnaires were conducted. The primary efficacy endpoints were the percent change in Healthy Hair Index 75 and Healthy Hair Index 50 measurements from baseline to the eighth month. Results: The Healthy Hair Index calculations, expressed as percent change from baseline to Month 4 and from baseline to Month 8, revealed that the MFSO® treatment group improved by 103.6 percent and 215.7 percent for the Healthy Hair Index 75 and 133.7 and 188.3 percent for the Healthy Hair Index 50 values, respectively. When compared with the vehicle and the argan oil brand groups, the Healthy Hair Index levels were significantly higher (p < 0.001) for the MFSO® treatment group, indicating a much greater ability to increase the levels of unbroken hairs by reducing hair breakage. With respect to the mean percent improvements from baseline to Month 4 and Month 8, the MFSO® hair oil treatment group was better than each of the other two treatment groups by at least 117.6 percent and 234.9 percent for the Healthy Hair Index 75 and 316.5 percent and 312 percent for the Healthy Hair Index 50 values, respectively, thereby achieving the primary efficacy objective. Subjects favored the MFSO® hair oil treatment, rating it as safe, effective, and aesthetically pleasing. Conclusions: The MFSO hair oil product is a safe and effective option for the treatment of women suffering from hair breakage and damaged hair.