Cinainu Shows Promise for Pediatric Alopecia Areata in Landmark RAAINBOW Trial

Cinainu Shows Promise for Pediatric Alopecia Areata in Landmark RAAINBOW Trial

By, Admin 24 July 2025

Legacy Healthcare’s Topical Botanical Drug Demonstrates Long-Term Efficacy and Safety Without Immunosuppression

Legacy Healthcare has announced a major milestone in pediatric dermatology: the British Journal of Dermatology has published results from the RAAINBOW Phase 2/3 trial, confirming the efficacy and safety of Cinainu in children and adolescents with moderate to severe alopecia areata (AA)—a chronic autoimmune disease marked by non-scarring hair loss and significant impairment in quality of life.

A Safer, Non-Immunosuppressive Approach for Children

Unlike existing treatments that rely on immunosuppressants such as oral JAK inhibitors, Cinainu is a topical botanical drug that has demonstrated significant hair regrowth without triggering immunosuppression-related adverse events. The results also suggest a persistent therapeutic effect, a first-of-its-kind outcome according to Legacy Healthcare CEO Saad Harti.

“Beyond its efficacy in regrowing patients' scalp hair, Cinainu has shown to treat this autoimmune disease without immunosuppression-related adverse events, and with persistent efficacy,” said Harti. “Publication in the British Journal of Dermatology marks a key milestone supporting Cinainu’s efficacy and safety.”

Unmet Needs in Pediatric AA Treatment

Alopecia areata is driven by inflammation and immune dysregulation, often involving IL-8 and JAK-dependent pathways. While oral JAK inhibitors have opened new doors for severe AA treatment in adults and adolescents, there is still a critical need for therapies that:

  • Are safe enough for early-stage intervention
  • Do not cause relapse upon discontinuation
  • Are suitable for children, the most vulnerable group

Cinainu—thanks to its safety profile in prior studies—was authorized for evaluation in both early and severe stages of AA in pediatric populations.

RAAINBOW Trial Overview: Efficacy at 24 and 48 Weeks

The RAAINBOW trial was an international, randomized, double-blind, placebo-controlled Phase 2/3 study involving 107 pediatric AA patients. Participants were randomized in a 2:1 ratio to receive either Cinainu or placebo for 24 weeks, followed by a 24-week treatment-free follow-up.

Key primary analysis included 62 patients with confirmed moderate-to-severe AA.

  • Primary Endpoint: Relative change in SALT score (a measure of scalp hair loss) from baseline to Week 24
  • Result at Week 24: Adjusted mean difference (95% CI) of +26.3% (0.1, 52.5) in favor of Cinainu, p = 0.0488, Cohen’s d = 0.52
  • Result at Week 48: Sustained benefit with a mean difference of +39.4% (13.1, 65.6), p = 0.0033, d = 0.80

Additional key outcomes at Week 48:

  • 47.6% of Cinainu-treated patients achieved SALT ≤20 vs 15.0% on placebo (p = 0.0129, NNT = 3.1)
  • 35.7% reached SALT ≤10 vs 10% on placebo (p = 0.0339, NNT = 3.9)
  • Quality-of-life scores improved with effect sizes between d = 0.61–0.79

Safety Profile: No Serious or Immunosuppressive Adverse Events

  • No serious adverse events were reported in the Cinainu group
  • Cinainu was well tolerated, with fewer adverse events than placebo
  • Reported events were mostly mild to moderate, local, and transient
  • Crucially, no immunosuppression-related events were observed

These findings strongly support Cinainu’s potential for safe, early intervention, especially in pediatric patients.

About Cinainu: Multi-Target Botanical Innovation

Cinainu is a topical botanical drug-candidate with a patent lasting until 2043. Its therapeutic action includes:

  • Reducing IL-8 and pro-inflammatory adhesion molecules (E-selectin, ICAM-1)
  • Restoring anti-apoptotic protein Bcl-2 to near-normal levels
  • Increasing Langerhans cell density in the epidermis
  • Enhancing scalp collagen content

Over 700 patients have been exposed to Cinainu in various trials (up to 12 months), including studies for androgenetic alopecia and chemotherapy-induced alopecia—all without significant safety concerns.

About Legacy Healthcare

Legacy Healthcare, based in Switzerland, develops botanical drug candidates derived from plants with well-established human safety profiles. Their focus is on treating chronic diseases by leveraging multi-target activity and natural compound synergy.

About the British Journal of Dermatology

The British Journal of Dermatology (BJD) is one of the highest-ranked international journals in its field, dedicated to publishing impactful research that advances skin disease treatment and improves patient outcomes. It is part of the British Association of Dermatologists.

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