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Hair Loss Treatments

Aclaris Therapeutics Announces Positive Phase 2 Clinical Trials For Genetic Hair Loss

A bio-pharmaceutical company called Aclaris Therapeutics, Inc has recently announced some exciting news for hair loss sufferers worldwide. The physician led bio-pharmaceutical company primarily focuses on immuno-inflammatory diseases. Recently, Aclaris Therapeutics announced positive results from their phase 2 open-clinical trial. The drug that is being tested is an investigational topical Janus Kinase (JAK) inhibitor. In this article, we will be discussing the phase 2 clinical trials of this investigational drug called ATI-502 for the treatment of male/female pattern baldness.

Who Is Aclaris Therapeutics, Inc?

Aclaris Therapeutics, Inc is a physician led bio-pharmaceutical company that focuses on immuno-inflammatory diseases and dermatological ailments that do not have treatment options. The company contains two FDA approved-approved medications, as well one-late stage investigational drug and another pipeline drug focusing on protein kinase regulation. The company focuses on areas such as warts, alopeica areata, and vitiligo.

Phase 2 Clinical Trials of ATI-502

The clinical trial evaluated 23 participants aged 18-50 years of age. The study contained both male and female participants. The subjects applied ATI-502 to their scalp twice daily for 26 weeks. Twenty three participants completed 6 months of treatment. The overall change noted from the study was an increase in hair count. The study showed an increase of 8.6 hairs per square centimeter (cm2). 

Participants who experienced increased hair growth were given a score from 1-3, 3 being the highest level of hair growth. Based on these scores, investigators rated 73% of their subjects experiencing increased hair growth-and 82% of participants rated themselves as experiencing hair growth.

Were There Any Negative Side Effects Reported In The Study?

ATI-502 was well tolerated, according to investigators there were no treatment related adverse-reactions. There was one unrelated serious adverse event of breast cancer reported, forcing one participant to withdraw from the clinical trial during the first week of treatment.

What's Next For ATI-502?

The 12 month results of this clinical trial are expected to be released by the end of 2019. Aclaris Therapeutics, Inc believe the next step is initiating a double-blind, randomized, controlled phase 2 clinical trial. The study may have a focus on female hair loss.

Bottomline

While the phase 2 clinical trials appear impressive, it is important to remember that the sample pool is small. Furthermore, the study is not a double-blind randomized-placebo controlled study. Thus, there is nothing to compare the results too. At this time, the drug ATI-502 is extremely early in it's developmental stage and only time will tell if the drug is ever FDA-approved for the treatment of androgenic alopecia (genetic hair loss).