Topical 2-Deoxy-D-ribose Hydrogel Versus Minoxidil 5% Solution for Androgenetic Alopecia

Overview

Androgenetic alopecia is a common form of hair loss that can affect quality of life. This randomized controlled trial aims to evaluate the efficacy and safety of topical 2-Deoxy-D-ribose (2dDR) hydrogel compared with topical minoxidil 5% solution in the treatment of mild to moderate androgenetic alopecia in adults aged 18 to 50 years. Sixty participants will be randomized into 2 treatment groups. The 2dDR group will apply 1 gram of topical 2dDR hydrogel once daily to the affected scalp areas for 6 months. The minoxidil group will apply topical minoxidil 5% solution to the affected scalp areas for 6 months according to sex-specific dosing in the protocol. Participants will undergo clinical assessment, trichoscopic evaluation, and standardized scalp photography at baseline, Week 12, and Week 24. The study will also assess tissue vascular endothelial growth factor (VEGF) levels using scalp biopsy specimens obtained at baseline and after 3 months of treatment in both groups. Safety will be evaluated through adverse event monitoring and clinical scalp examination during follow-up visits.

Androgenetic alopecia (AGA) is a common androgen-dependent, genetically determined form of hair loss characterized by progressive shortening of the anagen phase, prolongation of telogen, and miniaturization of hair follicles. It commonly affects the frontal scalp, mid-scalp, and vertex in males, and typically presents as diffuse thinning over the crown with preservation of the frontal hairline in females. In addition to hormonal and genetic factors, inflammatory and oxidative stress-related mechanisms have been implicated in the pathogenesis of AGA. Minoxidil is one of the currently approved treatments for AGA and is thought to improve hair growth through effects on scalp microcirculation, vascular endothelial growth factor (VEGF) expression, and direct stimulation of hair follicles. Recent preclinical studies have suggested that 2-Deoxy-D-ribose (2dDR), a deoxypentose sugar with pro-angiogenic properties, may stimulate angiogenesis through upregulation of VEGF and may promote hair regrowth. Based on these findings, this study is designed to compare topical 2dDR hydrogel with topical minoxidil 5% solution in patients with AGA and to investigate a possible mechanism of action through tissue VEGF assessment. This study is a randomized controlled trial that will include 60 adult participants aged 18 to 50 years with mild to moderate AGA. Eligible male participants will have Hamilton-Norwood grades II to V, and eligible female participants will have Ludwig grades I to II. Participants will be recruited from the dermatology outpatient clinic of Cairo University Hospital. After informed consent and screening, eligible participants will be randomized into 1 of 2 treatment groups. Participants in the 2dDR group will apply 1 gram (2 fingertip units) of topical 2dDR hydrogel once daily to targeted scalp areas for 6 months. Participants in the minoxidil group will apply topical minoxidil 5% solution to targeted scalp areas for 6 months, using 1 cc twice daily for men and once daily for women, as specified in the protocol. Clinical evaluations will include medical history, family history, assessment of disease severity, trichoscopy, and standardized global scalp photography. Trichoscopic assessments will include hair density, terminal hair density, vellus hair density, average hair thickness, follicular unit density, percentage of hairs per follicular unit, and average follicular hairs per unit in predefined scalp areas. Standardized photographs will be obtained at baseline, Week 12, and Week 24 and assessed by blinded dermatologists using a 7-point global photographic scale. Participants will also complete patient global assessment and patient satisfaction evaluation at Week 12 and Week 24. For biochemical assessment, scalp biopsy specimens will be obtained at baseline and after 3 months of treatment in both study groups to measure tissue VEGF levels by ELISA. In the 2dDR group, an additional biopsy will be obtained from a subset of participants after 3 months for histopathological evaluation of vascular proliferation, follicular thickness, and follicle count. The primary outcome measures are the changes in terminal hair density and total hair density after 12 weeks of treatment, as well as the change in tissue VEGF levels from baseline to Week 12. Secondary outcomes include changes in terminal and total hair density at Week 24, physician-rated global photographic assessment, patient global assessment, patient satisfaction, safety based on adverse events and scalp examination, and correlation of treatment response with clinical and demographic variables.