Clinical study: The efficacy of the Androhair laser comb
Clinical studies were performed under an Independent Review Board protocol at a leading research center to qualify and quantify the efficacies of the Androhair LaserComb as a medical device for use in treating Alopecia (hair loss). Both male and female patients, with ages ranging from 26 to 76, were included in a six month evaluation period. Study subjects were required to have thinning hair in the scalp area and have active hair loss at the time of entrance into the study. Analysis was conducted at two locations on the scalp, and in the temporal and vertex areas.
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Before use of the Androhair laser comb began, each area was clipped and a high-resolution photograph of the location was made. These photographs were loaded into an imaging system that identified each hair shaft. After magnification, a standard hair count was carried out and the number was recorded for comparison later in the study. Following the initial marking and hair count, each patient was provided with an Androhair laser comb. They were instructed to use it twice a week for the prescribed time of approximately 10 minutes, covering the entire scalp twice with each treatment.
Each month, the patient would return to the clinic to have the study areas clipped, new photographs taken and new hair counts recorded.
At the end of the six-month period, 97.4% of the patients in the study showed benefits from using the Androhair laser comb.
Additionally, 84.2% of study participants showed successful hair growth with an average hair count increase for all patients of over 45%. These numbers are significantly better than any other product tested to date for hair re-growth.
Study Response Criteria:
Benefit: Benefit to treatment was defined as lack of hair loss, or > 0% change from baseline in hair count.
Hair Growth: Success in hair growth was defined as an increase in hair count of > 11% from baseline.
Statistical Significance: All p-values for the study were statistically significant. The p-value (or the probability that a variant would assume a value greater than or equal to the observed value) for this study´s endpoint (<0.0001) indicates that the results of this study would have a very high probability of being valid across the general population. In other words, the general population of men and women suffering from hair loss would, in all probability, see the same hair count increases as seen by the patients in this study.
- User results vary from person to person. For example, a 61 year old male participant experienced an increase from 36 to 94 hairs per square centimeter, a 161% increase.
- Usage experience indicates that re-growth continues past the six-month mark.
- The decline in hair counts at the early stages of treatment is an indication of Telogen shedding which is induced by new hair growth pushing out the old, mature hair.
This study has conclusively shown that the Androhair laser comb is an effective modality to combat hair loss. Average hair count increases consistently show that the Androhair not only controls excessive hair loss that leads to balding, but that hair is stimulated back into normal, healthy growth patterns.
Additional multi-centered double blind sham controlled studies are currently underway.
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