Methods: For this feasibility study, the population was composed of males between the ages of 20 and 60 years who have been experiencing active hair loss within the last 12 months and the diagnosis of AGA.
They also had a Norwood-Hamilton classification of 3, 3A, 3 V, 4, 4A, or 5 for the hair thinning patterns and skin type I, II, III, or IV on the Fitzpatrick skin type scale.
This two-arm randomized, parallel group study design employed stratifying randomization to balance treatment assignment within three investigational centers with at least 2 subjects enrolled in each Fitzpatrick skin type.
Results: A statistically significant positive trend in hair growth was observed from this pilot study, to evaluate the efficacy of the novel cold X5 hairlaser device for treating male androgenic alopecia. From the repeated measures analysis of variance, difference in mean hair counts over time was statistically significant (F = 7.70; p-value <0.0001).
Subsequent, linear regression of mean hair counts at each time point was performed, and post-hoc analysis found an increasing trend of hair growth over time that was statistically significant (p-value <0.0001) with the estimated slope of 1.406. Increased hair counts from the baseline to the end of the 26-week period were found to be strongly significant (p-value = 0.0003).
Conclusion: Albeit, sham device failure and resultant missing data from the control group, the positive trend hair growth, was observed due to the chronic use of X5hairlaser device.
This positive benefit while in full agreement with other low laser hair devices requires intensive further investigation.Trial registration: NCT02067260