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Phase 2 trial finds topical STS01 1% improves SALT scores in patchy alopecia areataA New Topical Treatment Shows Promise for Patchy Hair Loss

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Key Takeaway
Consider STS01 1% as a potential topical option for patchy alopecia areata, pending phase 3 confirmation.

This was a phase 2, multicenter, randomized controlled trial involving 155 adult patients with mild to moderate patchy alopecia areata (10% to 50% scalp hair loss). Participants were randomized to receive either placebo or one of four doses of STS01 (a topical controlled-release nanoparticle formulation of dithranol/Prosilic) at 0.25%, 0.5%, 1%, or 2% daily for 6 months.

The primary outcomes were the proportion of patients achieving a ≥30% improvement in Severity of Alopecia Tool (SALT) score and the percentage change from baseline in SALT score. At 6 months, 75.9% of patients on STS01 1% achieved a ≥30% SALT improvement versus 36.7% on placebo (p=0.0037). The least squares (LS) mean percentage change in SALT score from baseline to end of treatment was -55.0% for STS01 1% compared to +0.6% for placebo (p<0.01). Significant improvements were also seen at 2, 4, and 6 months. For the secondary outcome of Clinical Global Impression improvement, 72.0% of the STS01 1% group improved versus 41.7% on placebo (p<0.05).

Safety data indicated the most commonly reported treatment-emergent adverse events were skin irritation reactions, which were mostly mild. Key limitations include the phase 2 design, a 6-month follow-up period, and the lack of reported absolute numbers and effect sizes for the outcomes. The comparator was placebo, not an active treatment. For clinical practice, these results suggest the 1% dose of this novel dithranol formulation shows promise for improving hair regrowth in this population, but its place in therapy remains uncertain pending phase 3 data.

Alopecia areata is an autoimmune disease. The body's own immune system mistakenly attacks the hair follicles. This causes hair to fall out, often in round patches on the scalp.

It affects millions of people worldwide. It can start at any age. The uncertainty is one of the hardest parts. Will the hair grow back? Will more spots appear?

For those with mild to moderate patchy hair loss, treatment options are surprisingly limited. There are no officially approved topical treatments. People often face a choice between watchful waiting or using strong medications not specifically designed for this condition.

The search for a simple, effective, and safe treatment has been urgent.

The old approach versus the new

Doctors have known about a medication called dithranol for decades. It’s been used for psoriasis. It can help calm an overactive immune response in the skin.

But it has a big problem. It’s messy, stains skin and clothing, and often causes significant irritation. This made it a poor practical choice for treating the scalp.

Here’s the twist.

Scientists didn't give up on the medicine. They reinvented how to deliver it.

A smarter delivery system

This new treatment, called STS01, contains dithranol. But it’s packaged inside tiny, engineered particles called nanoparticles.

Think of these nanoparticles like advanced delivery trucks. They are designed to carry the medicine precisely to the hair follicle—the root of the problem. They release the drug slowly and steadily.

This controlled release is the key. It aims to provide the therapeutic effect where it’s needed. But it may reduce the mess and severe irritation of the old formula.

It’s a classic case of a new solution for an old problem.

A closer look at the study

Researchers conducted a rigorous Phase 2 trial. They enrolled 155 adults with mild to moderate patchy alopecia areata.

Participants were randomly assigned to use one of four strengths of the STS01 cream or a placebo cream. They applied it daily for six months. Neither they nor their doctors knew which one they were using.

The main goal was to see who achieved significant hair regrowth.

The promising results

The results were clear. The 1% strength of STS01 was the standout.

After six months, 75.9% of people using STS01 1% saw significant regrowth. In the placebo group, only 36.7% did. That’s more than double the response rate.

Scientists measure regrowth with a SALT score. It calculates the percentage of scalp hair loss. A lower score means more hair.

On average, people using the 1% cream saw their SALT score drop by 55% by the end of treatment. The placebo group saw essentially no change. The improvement started as early as two months.

Perhaps just as importantly, 72% of patients and their doctors reported a visible global improvement in their condition with the 1% strength.

But there is a catch.

This doesn’t mean the treatment is available yet.

The most common side effect was skin irritation, like redness or itching. For most, it was mild to moderate. About 12% of people using the active cream stopped due to skin reactions.

The irritation was often manageable by using the cream less frequently. This is a common trade-off in dermatology. The treatment that works often comes with some local side effects that need to be managed.

Phase 2 trials are designed to find the right dose and see if a treatment works. This study successfully did both. It identified the 1% strength as optimally effective and established a clear dose response.

The results provide a strong signal of efficacy. This gives researchers the confidence they need to move forward.

STS01 is still an investigational drug. You cannot get a prescription for it today.

This research is a critical and promising step. But it is still a step in the process. The most important thing you can do now is talk to a dermatologist about your current options.

Understanding the limitations

This was a Phase 2 trial. It is larger than early studies but not as large as the final-phase trials needed for approval. The six-month treatment period gives us good medium-term data, but longer-term safety and effectiveness will need more study.

The side effects, while manageable for most, are a real consideration. Finding the balance between effectiveness and tolerability will be key for each individual.

Based on these positive results, the developers plan to move STS01 1% into a Phase 3 clinical trial. This is the final, large-scale study required to seek official approval from health authorities like the FDA.

Phase 3 trials take time. They involve more patients and longer follow-up. If successful, an application for approval would follow. The entire process means it could still be a few years before this treatment might potentially reach patients.

For now, it represents a hopeful new direction. It shows that innovative thinking can breathe new life into old medicines. It offers a tangible glimpse of a future where treating patchy hair loss could be as simple as applying a cream.

Study Details

Study typeRct
Sample sizen = 32
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
Background There are no licensed treatments for patients with mild to moderate patchy alopecia areata (AA). Objectives To evaluate the efficacy, safety and dose response of STS01, a novel nanoparticle controlled release, topical formulation of dithranol/Prosilic. Methods In a phase 2, double blind study, adult patients with mild to moderate AA (guideline 10% to 50% of scalp hair loss) were randomly assigned to STS01 at doses of 0.25%, 0.5%, 1%, 2% or placebo, daily for 6 months. The primary endpoints included the proportion of patients achieving a >=30% improvement in Severity of Alopecia Tool (SALT) score, and percentage change from baseline in SALT score. This minimum level of improvement is generally accepted as an indicator of the population likely to progress to complete regrowth Results A total of 155 patients were randomized and treated (placebo, n=32; STS01 groups, n=30 to 31). STS01 1% met the primary efficacy endpoint of >=30% SALT score improvement compared to placebo: 75.9% (95% CI, 60.3 to 91.4%) vs 36.7% (95% CI, 19.4 to 53.9%) at 6 months; p=0.0037. The least squares (LS) mean percentage change in SALT score from baseline to end of treatment showed a clear dose response relationship; STS01 0.5% was the minimally effective dose and 2% the maximum tolerated dose, and there was a statistically significant improvement in the STS01 1% group (minus 55.0% vs +0.6% with placebo; p<0.01). Significant improvements (p<0.05) in LS mean percentage changes from baseline in SALT scores were demonstrated in the STS01 1% group at 2 months (-28.6% vs 12.8%), 4 months (-57.2% vs 1.5%), and 6 months (minus 67.0% vs 0.6%). Clinical Global Impression improvement was reported in 72.0% of patients with STS01 1% vs 41.7% with placebo (p<0.05). The most commonly reported treatment emergent adverse events were skin irritation reactions, but were mostly mild (STS01: 56.7% to 71.0%; placebo: 21.9%) or moderate (STS01:13.3% to 35.5%; placebo: 0%) and manageable by reduced frequency of application. There were 15 skin-related discontinuations with STS01 (12.2%) and 2 (6.3%) with placebo. Conclusions STS01 demonstrated a clear dose response, with STS01 1% dose optimally more effective than placebo for hair regrowth with minimal tolerance concerns in mild to moderate patchy AA. Skin irritation reactions were generally manageable and there were no new safety signals. Further characterisation of the STS01 1% dose is planned in a phase 3 study. Chief Investigator AGM reports fees from Soterios Ltd. Chief Statistician DMF is an employee of Soterios Ltd. All other authors were Principal Investigators in the trial and their clinics were reimbursed for the work involved. Most also had sponsorship in the form of consultancies, investigational roles or lecturing roles on behalf of other Dermatological pharmaceutical companies
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