You may remember that last year, Alopecia UK shared a recruitment advert for a clinical trial by UK-based pharmaceutical company Soterios. In this phase 2 clinical trial, people with mild-to-moderate alopecia areata (affecting <50% of their scalp) were invited to use the topical treatment STS-01. This trial has now finished, and Soterios have shared their results with us, which look promising.  

In this research study, participants with mild-to-moderate alopecia areata were given one of four doses of the treatment, or a placebo. They applied a cream containing 2%, 1%, 0.5%, 0.25% or 0% (placebo) of the active ingredient to their scalp, once a day. In total, 158 participants completed this study. 

The threshold for success, a meaningful improvement in scalp hair growth, was set as a 30% or higher improvement in the SALT score after 24 weeks of treatment. The SALT score is the tool that is used to objectively measure scalp hair coverage, and essentially describes the proportion of the scalp that has hair. For example, someone with patches covering 20% of their scalp would have a SALT 20. A >30% improvement in the SALT score would mean that someone starting with, for example, 40% hair loss went down to 28% or lower scalp hair loss. For a more in-depth explanation of the SALT score, see our page on this.

In this clinical trial, 75.9% of participants using the once-daily 1% cream had a 30% or higher improvement in scalp hair coverage after 24 weeks. This was more than in the placebo group, in which 36.7% of participants had a 30% or higher improvement in scalp hair coverage. We know that spontaneous regrowth (without medical treatment) is common in people with mild-to-moderate alopecia areata, so it is not surprising that some people in the placebo group also had regrowth. Nevertheless, these results suggest that STS-01 can improve hair regrowth in people with <50% scalp hair loss due to alopecia areata.  

In addition, 19% of participants on the 1% cream, and 27% of participants on the 2% cream, had full scalp hair regrowth (SALT score 0). In the placebo group, only 3% of participants experienced full scalp hair regrowth. Soterios also report that the cream was well tolerated by participants and there were no major undesired effects of the treatment.

Currently, when people with mild-to-moderate alopecia areata are prescribed treatment by a healthcare professional, they are often given topical corticosteroids, which are also applied as a cream. However, this treatment by Soterios uses a different active ingredient. They suggest it works by dampening the inflammatory response that is present in the hair follicles of people with alopecia areata, and changes the behaviour of immune cells attacking the hair. 

This phase 2 study included 158 people with alopecia areata. Soterios plan to share the full results of this study at a future scientific conference, so further details will become public at a later date. They will now look to undertake a larger phase 3 study, to test the effectiveness and safety of the optimal dose of this treatment in more people. Their intention is to get an approved treatment for mild-to-moderate alopecia areata available to patients as soon as possible.