#Switzerland #Lausanne #Alopecia #Cinainu #Legacy Healthcare

Legacy Healthcare’s Promising Phase 2/3 Results

In a groundbreaking publication in the British Journal of Dermatology, Legacy Healthcare has recently shared the results of their RAAINBOW Phase 2/3 trial regarding a new treatment for moderate to severe alopecia areata (AA) called Cinainu. This chronic autoimmune condition results in significant hair loss and can severely impact the quality of life of those affected, notably children and adolescents. The findings of this trial not only highlight the efficacy of Cinainu but also provide hope in an area where treatment options have been limited.

Significance of the Trial

The RAAINBOW trial stands out as it is the first study targeting pediatric patients suffering from AA using a comprehensive approach that excludes immunosuppression. Saad Harti, the founder and CEO of Legacy Healthcare, emphasized that the results mark a significant advancement in treatment, stating that "Cinainu not only promotes hair regrowth but does so without any adverse immunosuppression effects, demonstrating lasting efficacy after treatment cessation."

Study Design and Results

The international, double-blind, placebo-controlled trial enrolled 107 pediatric patients diagnosed with moderate to severe AA, half of whom received the Cinainu treatment over a period of 24 weeks, followed by an additional 24-week treatment-free observation phase. The primary endpoint revolved around the change in the Severity of Alopecia Tool (SALT) scores, assessing hair loss percentages among participants.

Statistical analysis showed that the Cinainu group experienced a substantial relative change in their SALT scores compared to the placebo, recorded at an adjusted mean difference of +26.3% at Week 24, with a p-value of 0.0488 indicating strong statistical significance. More impressively, during the follow-up period, this benefit appeared to sustain, with a confirmed score enhancement of +39.4% at Week 48, suggesting the treatment's long-term effectiveness.

Additionally, more than 47% of the Cinainu group achieved scores indicating significant hair regrowth (SALT ≤20), compared to only 15% in the placebo group. These extraordinary results underline the treatment's potential life-changing outcomes for pediatric patients suffering from AA.

Quality of Life Improvements

Moreover, the trial indicated marked improvements in patients’ quality of life after just 24 weeks of treatment, with effect sizes ranging from d=0.61 to 0.79. The treatment was reported to be safe and well-tolerated, with no severe adverse effects recorded. The nature of reported side effects was generally mild and transient, focusing largely on localized reactions.

The Future of Alopecia Areata Treatment

Cinainu's success is attributed to its carefully curated formulation, which possesses anti-inflammatory, anti-apoptotic, and antioxidant properties. This botanical topical is anticipated to redefine treatment modalities for AA, particularly in children—often considered a vulnerable demographic. Already authorized for evaluation in children, it brings hope for a demographic that has faced a significant gap in effective treatment options.

Legacy Healthcare: A Vision for Chronic Diseases

Switzerland-based Legacy Healthcare aims to capitalize on the safety and pleiotropic effects of herbal constituents that are historically recognized for human use. With future plans for further research and application, the journey for Cinainu signifies not only a remarkable achievement for the company but also a transformative step for those grappling with alopecia areata.

Conclusion

As we look ahead, the recent publication in the British Journal of Dermatology serves as a foundation for advancing the knowledge and management of this distressing condition. The potential of Cinainu is immense, and its compassionate application may soon provide change for countless lives while reinstating confidence and hope in young patients battling alopecia areata.