Topical sodium valproate-loaded nanospanlastics versus conventional topical steroid therapy in alopecia areata: a randomized controlled study

Rania M Mogawer; Marwa Mohamed Fawzy; Ahmed Mourad; Heba Ahmed; Maha Nasr; Zeinab Ahmed Nour; Vanessa Hafez

doi:10.1007/s00403-023-02785-1

Topical sodium valproate-loaded nanospanlastics versus conventional topical steroid therapy in alopecia areata: a randomized controlled study

Arch Dermatol Res. 2024 Jan 3;316(2):64. doi: 10.1007/s00403-023-02785-1.

Authors

Rania M Mogawer¹, Marwa Mohamed Fawzy², Ahmed Mourad², Heba Ahmed², Maha Nasr³, Zeinab Ahmed Nour⁴, Vanessa Hafez²

Affiliations

¹ Dermatology Department, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt. Raniamogawer@kasralainy.edu.eg.
² Dermatology Department, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt.
³ Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
⁴ Biochemistry Department, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt.

Abstract

Background: A myriad of therapeutic modalities for alopecia areata are available; however, none is of high level of evidence, creating an immense need for the evaluation of other treatment modalities, of which topical sodium valproate is of potential role via proposed decrease in beta-catenin breakdown, despite its well-known side effect of hair fall as an oral therapy.

Objective: Evaluating the efficacy and the safety of sodium valproate (SV)-loaded nanospanlastics, in comparison to topical corticosteroids, this is the currently available gold standard topical treatment for patchy AA.

Methodology: A total of 66 patients with patchy AA were randomly assigned to receive either topical mometasone furoate lotion or topical SV applied twice daily to all patches except a control patch, which was left untreated. Clinical, trichoscopic and biochemical assessments of beta-catenin tissue levels and Axin-2 gene expression were carried out at baseline and after 3 months.

Results: Both therapeutic modalities were comparable. Potential efficacy was highlighted by significant improvement in the representative patch, the largest treated patch, to the control patch, the smallest untreated patch in both steroid and valproate groups (p = 0.027, 0.003 respectively). Both beta-catenin levels and Axin-2 gene expression were reduced after treatment, pointing to the inhibitory effect of dominating uncontrolled inflammatory milieu. Baseline beta-catenin was found to significantly negatively correlate with improvement in the representative patch in patients with baseline level above 0.42 ng/ml (p = - 0.042).

Conclusion: Both topical SV and steroids are of comparable modest efficacy. Thus, further evaluation of SV is due in combination with intralesional steroids and other anti-inflammatory treatment modalities, together with developing individualized approaches based on baseline beta-catenin level.

Gov identifier: NCT05017454, https://clinicaltrials.gov/ct2/show/NCT05017454 .

Keywords: Alopecia areata; Beta-catenin; Sodium valproate; Steroids.

Publication types

Randomized Controlled Trial

MeSH terms

Alopecia Areata* / drug therapy
Axin Protein
Humans
Treatment Outcome
Valproic Acid / therapeutic use
beta Catenin

Substances

Valproic Acid
beta Catenin
Axin Protein

Supplementary concepts

Diffuse alopecia

Associated data

ClinicalTrials.gov/NCT05017454