Aclaris Positive 6 Month Results In AGA With Photos

On June 17, 2019, Aclaris Therapeutics Inc. issued a press release announcing positive results from a phase 2 clinical trial for men and women with androgenic alopecia.

Trial Details

From the press release: the trial results included 22 subjects of both men and women who applied a 0.46% solution of ATI-502 to their scalps twice daily over a period of 26 weeks or 6.5 months. ATI-502 is the product name of Aclaris’ topical JAK 1/3 inhibitor.

The primary evaluation point of this study was the non-vellus target area hair count (TAHC) after 26 weeks.

Subjects received a tattoo on their scalp to indicate the area of treatment precisely.

The overall average increase in target area hair count among all subjects was 8.6 hairs per cm².

In females alone, the TAHC increase was 15.3 hairs/cm².

In males alone, the TAHC increase was 5.6 hairs/cm².

The secondary evaluation point was an investigator global assessment (IGA) and a self global assessment (SGA). This basically means the investigator and the subject physically observed the scalp of the subject and gave their opinion on how much hair was grown.

The investigators rated 73% (16 of 22) of the subjects as experiencing increased hair growth.

82% (18 of 22) of the subjects rated themselves as having increased hair growth.

The Male And Female Response

The above slide displays the increase in hair growth over a period of 26 weeks. The black line represents the male response and the red line represents the female response. As you can see, the males displayed a much higher increase in hair growth at the 8 week mark, about 17 hairs per cm² compared to the female increase of about 7 hairs per cm². Curiously, by the end of the 26 week trial these roles had almost reversed as was noted in the trial details section above this slide.

Photo Evidence

This is what you came here for. Below are some photo images of a 48 y/o male and a 31 y/o female who both completed the 26 week trial period and applied ATI-502 to their scalps twice daily.

The photo displays meaningful restoration of the crown area. The balding area has shrunk to about half its original size at week 26. The professional photography settings are, of course, consistent in both photos. Both male subject and the investigator rated this result as “greatly increased” hair growth. As a reference point, this subject displays a TAHC increase of 11 hairs per cm².



The parting of the hair in this 31 y/o female has shrunk by week 26. The quality of her hair also seems thicker and healthier beyond the part. The investigator rated this as a “slight” increase in hair growth while the woman rated herself as having a “moderate” increase in hair growth. The TAHC was an increase of 15 hairs per cm².

What do the readers think of these photographs? Please comment below.

Next Steps For Aclaris

Due to the positive nature of the results of this trial, Aclaris has decided to continue the length of the trial to 12 months. Data will be recollected and evaluated at that time and Acalris hopes to show a continued mark of improvement among trial participants at that time.

Aclaris has also stated they have been working on an improved topical formulation of ATI-502 which includes higher concentrations of the active ingredient. The formula being currently trialed was a 0.46% solution and Aclaris believes they can create a formula about 5X greater concentration than this. Wow.

Thus, another phase 2 dose ranging trial with higher concentrations of ATI-502 is being evaluated by Aclaris at this time. The press release states that this trial may potentially have a female focus and could be underway in H1 2020. The timeline may be potentially disappointing to readers, however progress is progress.

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