Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05017454
Study type	Interventional
Source	Kasr El Aini Hospital
Contact
Status	Completed
Phase	Early Phase 1
Start date	May 1, 2021
Completion date	April 1, 2023

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See also
Status	Clinical Trial	Phase
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Completed	`NCT02812342` - Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants	Phase 2
Completed	`NCT02350023` - Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata	Phase 4
Completed	`NCT02018042` - An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata	Phase 2
Terminated	`NCT01898806` - Intralesional Steroids in the Treatment of Alopecia Areata	Phase 4
Recruiting	`NCT04011748` - Clinical Application of Stem Cell Educator Therapy in Alopecia Areata	Phase 2
Terminated	`NCT04517864` - PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA	Phase 2
Not yet recruiting	`NCT05803070` - Topical Cetirizine in Treatment of Localized Alopecia Areata
Not yet recruiting	`NCT05496426` - A Study of KL130008 in Adults With Severe Alopecia Areata	Phase 2
Completed	`NCT04147845` - Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata	N/A
Terminated	`NCT03325296` - Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.	Phase 2
Recruiting	`NCT05635266` - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Enrolling by invitation	`NCT05745389` - CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
Recruiting	`NCT04246372` - Tofacitinib for Immune Skin Conditions in Down Syndrome	Phase 2
Not yet recruiting	`NCT06087796` - Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata.	Phase 1
Withdrawn	`NCT03532958` - Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata	Phase 2
Recruiting	`NCT02604888` - Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females	N/A
Terminated	`NCT01385839` - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata	N/A
Completed	`NCT00408798` - Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms