Document Type
Poster Presentation
Location
Oxford Conference Center, Oxford MS
Event Website
https://oxfordicsb.org/
Start Date
8-4-2025 11:30 AM
Description
Background: Alopecia areata (AA) is a debilitating autoimmune-mediated disorder marked by non-scarring hair loss. It significantly impairs patients' quality of life. Unmet needs persist, particularly for pediatric patients and patients with moderate AA. Cinainu, a topical solution containing four botanical drug substances, may address these gaps due to its anti-inflammatory, anti-apoptotic, and antioxidant properties. Objective: This phase 2/3 study evaluated the efficacy and safety of cinainu in children and adolescents with moderate-to-severe AA. Methods: The RAAINBOW study, an international, double-blind, placebo-controlled trial, involved 107 pediatric patients randomly assigned (2:1) to receive cinainu or placebo for 24 weeks, followed by a 24-week untreated follow-up period. The primary endpoint was the relative change in Severity of Alopecia Tool (SALT) score from baseline to Week 24. Secondary outcomes included responder rate (≥40% improvement in SALT score from baseline to Week 24). Results: Cinainu showed significant benefits compared to placebo in relative change in SALT score from baseline to Week 24: adjusted mean difference +26.3%, p=0.0488, Cohen’s d=0.52. A significantly higher proportion of cinainu-treated patients met responder criteria at Week 24 (26.2% vs 5.0%, p=0.0484). Cinainu also led to significant quality of life improvements at Week 24, with effect sizes of d=0.63 in CDLQI and d=0.75 in EQ-VAS. Cinainu showed sustained benefits during the untreated follow-up period: adjusted mean difference +39.4%, p=0.0033. No serious adverse events were related to cinainu, and treatment was well-tolerated. Conclusion: Cinainu demonstrated promising efficacy and safety for moderate-to-severe AA in children and adolescents, with sustained benefits observed during the follow-up period. Given its favorable risk-benefit profile, cinainu could serve as a treatment option for AA in children and adolescents, addressing important unmet needs.
Recommended Citation
HARTI, SAAD and Blume-Peytavi, Ulrike, "Efficacy and safety of a prescription botanical drug, cinainu, in pediatric alopecia areata: an international, double-blind, randomized, placebo-controlled, phase 2/3 trial" (2025). Oxford ICSB. 19.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/19
Publication Date
April 2025
Included in
Efficacy and safety of a prescription botanical drug, cinainu, in pediatric alopecia areata: an international, double-blind, randomized, placebo-controlled, phase 2/3 trial
Oxford Conference Center, Oxford MS
Background: Alopecia areata (AA) is a debilitating autoimmune-mediated disorder marked by non-scarring hair loss. It significantly impairs patients' quality of life. Unmet needs persist, particularly for pediatric patients and patients with moderate AA. Cinainu, a topical solution containing four botanical drug substances, may address these gaps due to its anti-inflammatory, anti-apoptotic, and antioxidant properties. Objective: This phase 2/3 study evaluated the efficacy and safety of cinainu in children and adolescents with moderate-to-severe AA. Methods: The RAAINBOW study, an international, double-blind, placebo-controlled trial, involved 107 pediatric patients randomly assigned (2:1) to receive cinainu or placebo for 24 weeks, followed by a 24-week untreated follow-up period. The primary endpoint was the relative change in Severity of Alopecia Tool (SALT) score from baseline to Week 24. Secondary outcomes included responder rate (≥40% improvement in SALT score from baseline to Week 24). Results: Cinainu showed significant benefits compared to placebo in relative change in SALT score from baseline to Week 24: adjusted mean difference +26.3%, p=0.0488, Cohen’s d=0.52. A significantly higher proportion of cinainu-treated patients met responder criteria at Week 24 (26.2% vs 5.0%, p=0.0484). Cinainu also led to significant quality of life improvements at Week 24, with effect sizes of d=0.63 in CDLQI and d=0.75 in EQ-VAS. Cinainu showed sustained benefits during the untreated follow-up period: adjusted mean difference +39.4%, p=0.0033. No serious adverse events were related to cinainu, and treatment was well-tolerated. Conclusion: Cinainu demonstrated promising efficacy and safety for moderate-to-severe AA in children and adolescents, with sustained benefits observed during the follow-up period. Given its favorable risk-benefit profile, cinainu could serve as a treatment option for AA in children and adolescents, addressing important unmet needs.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/19