Kasralainy Hospital, Dermatology Department
Cairo, Egypt
NCT Number: NCT05017454
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
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Notify Me12 year and older
All sexes
Interventional
Early Phase 1
Cairo, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
participants will apply the optimized sodium valproate-loaded nanospanlastic dispersion twice daily, on the affected areas of the scalp for 3 months
participants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months
Time frame: 6 months
defined by achieving ≥ 50% reduction in baseline SALT score at end-of-study and/or achieving patient global assessment of improvement (PGAI) ≥ 50%.
Time frame: 3 months
Assessment of expression of both beta-catenin and Axin2 in lesional scalp of patients with patchy AA before and after treatment with sodium valproate-loaded nanospanlastics, in comparison to conventional therapy with topical steroids
Time frame: 3 months
This evaluation will determine the number of dystrophic hairs in the patch area at baseline to be compared after the end of treatment. Markers for dystrophic hairs include exclamation-mark hairs, black dots, yellow dots and pigtail regrowing hair. The percentage of dystrophic hairs will be evaluated on a four-point scale: 3, > 50%; 2, 30-50%; 1, 1-29%; 0, no dystrophic hairs
Time frame: 3 months
Patient global assessment of improvement will be evaluated at the end of study, and will be scored as the following; (0 =no regrowth; 1 = <25% of regrowth; 2 = 25%-49% of regrowth; 3 = 50%-74% of regrowth; 4 = 75%-99% of re- growth; 5 = 100% of regrowth)
Time frame: 3 months
Clinical satisfaction of each patient will be made using a 10-point visual analogue scale (VAS, 0-10; the 0 level was defined as "Not satisfied at all," while a level of 10 was defined as "completely satisfied")
Time frame: 3 months
Subjective assessment of any encountered adverse effects (burning, itching) will also be performed. This will be determined on a four-point scale: 3, strong sensation; 2, moderate sensation; 1, mild sensation; 0, no itching or burning sensation
Time frame: 3 months
Patient satisfaction regarding characteristics of the used topical treatment, for example (texture, spreadability, hair matting, odour). This will be evaluated on a 3-point scale; 0=unsatisfied, 1=moderately satisfied, 2=extremely satisfied
Time frame: 3 months
Dermatology Life Quality Index (DLQI) will be evaluated at baseline and at the end of therapy, using a validated DLQI questionaire
Time frame: 6 months
Patients who achieved 100% reduction in baseline SALT after 3 months of treatment (end of therapy) were followed up for additional 3 months (end of study) to monitor any relapses.
Kasr El Aini Hospital
Other
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
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