Interview with Clinical Study Participant
Posted by Fran Dubsky

Lexington International is in the process of conducting numerous clinical research studies on the use of the HairMax in the treatment of androgenetic alopecia (pattern baldness) in both men and women. We recently completed a trial on the HairMax in men comparing the active device to a control sham device. While we are compiling the results for regulatory filing, we decided to interview Greg, who was a participant in the trial to get his feedback on his participation in the study. Clinical trials are vitally important in helping to expand knowledge of treatment options and we thought you might like to learn about what it was like to take part in a study of its kind.

Greg first began to notice changes in his condition in his mid-40’s. He noticed his hair starting to recede in the front and in the vertex (top of the head) and temporal (side of the head) regions. He did not experience excessive hair loss, just a general recession of the frontal hair line and thinning at the temporal regions of his head, but states he still had a ‘decent’ amount of hair and he was not experiencing ‘frank’ balding. His father did not have male pattern baldness as Greg defines it- he said he had all his hair into his 80’s.

He did not try to treat his hair loss in any way, but did look at a number of sites on the internet regarding hair transplants. However, he did not seek medical advice.

He stated that his hair loss made him feel older than he was and he felt a loss of self-esteem and thought that his professional image might be suffering because of it.

Greg heard about the study and thought that it might be worth a try, but he had no real expectations as to the outcome of the study. His was concerned upon entering the study, was whether he would be spending 6 months using a placebo instead of a real device and therefore see no results. He was also concerned that since he had a pretty good amount of hair, whether a real difference would be seen at the completion of the clinical trial.

Greg said that the study appealed to him because it was a non-drug device and seemed simple to use without a lot of ‘hassle’. He had no problem with the number of visits, etc. He found the staff at the research site to be helpful and professional.

Greg said he complied with the regimen using the device 3 times a week for about 11 minutes at each session. He used the device all over his scalp, but did concentrate on the front area which is where he particularly wanted to regrow hair.

He had absolutely no idea he was on the active device until about mid-way through the study he and others started to notice and comment that his hair appeared thicker all over. He did not experience hair regrowth in the front where the hair was permanently lost, but what was there grew more hair and thickened as did the temporal area. Of course, by then he knew he had an active device. His results were verified by the hair count changes that took place in the target region studied on his scalp which showed that 20% more hairs grew from the beginning of the study to its completion. (These quantitative results are highly significantly better when compared to results found with the sham control device in the study which demonstrated little if any regrow of hair.)

Greg experienced no initial hair shedding when he began therapy and in fact seemed, as the study progressed, to notice fewer shed hairs in the shower each day.

 While Greg saw no changes to his scalp itself from using the device, the change he noticed and was excited about was the increased hair growth and thickening of his hair. These changes made him feel better about his hair condition and he was glad that others also noticed the change.

Overall, Greg feels that the device definitely works, and definitely yielded real visible benefits and that the time spent participating in the study was well worth it. We appreciate his efforts in contributing to bringing to market effective treatment options for people with pattern baldness and hope you enjoyed his story.

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