NCT05017454

Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids

Assessment of Efficacy and Safety of Sodium Valproate -Loaded Nanospanlastics in Patients With Patchy Alopecia Areata in Comparison to Conventional Therapy With Topical Steroids: a Randomized Controlled Study, With Clinical, Dermoscopic and Molecular Asessements

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

the aim of this study is to assess the efficacy and safety of sodium valproate-loaded nanospanlastic in the treatment of patchy AA, in comparison to conventional therapy with topical steroids

Detailed description

Alpopecia Areata (AA) is the second common cause of non-scarring hair loss, the disease has huge negative impact on patients' quality of life, social and psychological status. The underlying pathogenesis of AA is not fully characterized, Yet the collapse of immune privilege and generation of autoimmune attack against unknown follicular antigens are the most agreed-upon theories behind the disease. In spite of various therapeutic armamentariums available for AA, no single agent has been proven efficacious regarding reversing hair loss and establishing long-term response. keeping in mind the burden of the disease together with lacking effective treatments, a need for further therapies is colossal. Wnt-b catenin pathway is one of the crucial signalling pathways that regulate hair cycling. An increasing body of evidence is supporting the fact that wnt-b catenin pathway is inhibited in AA, and therefore contributing to the hair loss that characteize the disease. Sodium valproate (SV), a well-known anti-epileptic drug, was found to inhibit Glycogen synthase kinase-3beta (GSK3β) in neuronal cells as one of the possible antiepileptic mechanisms of SV. GSK3B is a well-known inhibitor of β-catenin activity in dermal papilla cells (DPCs), and thus induces catagen-like changes in these cells. So the idea of using topical SV to promote hair regrowth via activation of b catenin came up and attracted the interests of investigators. recently an optimized sodium valproate-loaded nanospanlastics topical formula promisingly achieved clinical equivalence with 5% minoxidil lotion in AGA, with a superior safety profile to minoxidil

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	the optimized sodium valproate-loaded nanospanlastic dispersion	participants will apply the optimized sodium valproate-loaded nanospanlastic dispersion twice daily, on the affected areas of the scalp for 3 months
DRUG	mometasone furoate lotion	participants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-01-01
• Completion: 2023-04-01
• First posted: 2021-08-23
• Last updated: 2023-06-13

Locations

1 site across 1 country: Egypt