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

Efficacy & Safety of Topical 2-Deoxy-D-ribose Hydrogel Versus Minoxidil 5% Solution in Treatment of Androgenetic Alopecia: A Clinical & Biochemical Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Drug: Topical 2-Deoxy-D-ribose Hydrogel; Drug: Topical Minoxidil 5% Solution

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Ahmed; Phone Number: +201016532351; Email: heba.a.abdelgayed@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11555
      • Recruiting
      • Kasr El Aini Hospital
      • Contact: Heba Ahmed, Lecturer of Dermatology; Phone Number: +201016532351; Email: drhebaahmedyt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 to 50 years.
• Male and female patients with androgenetic alopecia.
• Mild to moderate disease severity, defined as Hamilton-Norwood scale II to V in males and Ludwig scale I to II in females.
• Ability and willingness to provide written informed consent.

Exclusion Criteria:

• Other types of hair loss, including inflammatory or scarring alopecia.
• Psoriasis.
• Inflammatory scalp dermatoses.
• History of severe systemic disease, including renal, cardiovascular, or hepatic disease.
• Chemotherapy during the last 5 years.
• Pregnancy.
• Lactation.
• Bleeding disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical 2-Deoxy-D-ribose Hydrogel; Participants assigned to this arm will apply 1 gram (2 fingertip units) of topical 2-Deoxy-D-ribose hydrogel once daily to the targeted scalp areas for 6 months.	Drug: Topical 2-Deoxy-D-ribose Hydrogel; Topical 2-Deoxy-D-ribose hydrogel prepared with sodium alginate. The hydrogel will be composed of sodium alginate, propylene glycol, 2-phenoxyethanol, and 2-Deoxy-D-ribose in water. Participants will apply 1 gram once daily to targeted scalp areas for 6 months.
Active Comparator: Topical Minoxidil 5% Solution; Participants assigned to this arm will apply topical minoxidil 5% solution to the targeted scalp areas for 6 months. Male participants will apply 1 cc twice daily, and female participants will apply 1 cc once daily.	Drug: Topical Minoxidil 5% Solution; Topical minoxidil 5% solution administered to targeted scalp areas for 6 months. Male participants will apply 1 cc twice daily, and female participants will apply 1 cc once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Terminal Hair Density	Change in terminal hair density in the predefined trichoscopic assessment areas after 12 weeks of treatment, compared between the topical 2-Deoxy-D-ribose hydrogel group and the topical minoxidil 5% solution group.	Baseline to Week 12
Change in Total Hair Density	Change in total hair density in the predefined trichoscopic assessment areas after 12 weeks of treatment, compared between the topical 2-Deoxy-D-ribose hydrogel group and the topical minoxidil 5% solution group.	Baseline to Week 12
Change in Tissue VEGF Level	Change in tissue vascular endothelial growth factor (VEGF) levels from baseline to Week 12, measured using scalp biopsy specimens in both treatment groups.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Terminal Hair Density at Week 24	Change in terminal hair density in the predefined trichoscopic assessment areas after 24 weeks of treatment, compared between the topical 2-Deoxy-D-ribose hydrogel group and the topical minoxidil 5% solution group.	Baseline to Week 24
Change in Total Hair Density at Week 24	Change in total hair density in the predefined trichoscopic assessment areas after 24 weeks of treatment, compared between the topical 2-Deoxy-D-ribose hydrogel group and the topical minoxidil 5% solution group.	Baseline to Week 24
Global Photographic Assessment	Change in standardized scalp photographs assessed independently by 3 blinded dermatologists using a 7-point modified physician global assessment scale ranging from -3 (significant disease progression) to 3 (excellent improvement).	Week 12 and Week 24
Patient Global Assessment	Participant-reported overall improvement using a 5-point scale: 0 = no improvement, 1 = mild response (less than 25%), 2 = moderate response (25% to 49%), 3 = good response (50% to 74%), and 4 = very good response (75% or more).	Week 12 and Week 24
Patient Satisfaction Score	Participant-reported treatment satisfaction using a 10-point visual analogue scale ranging from 0 (not satisfied at all) to 10 (completely satisfied).	Week 12 and Week 24
Correlation of Treatment Response With Clinical and Demographic Variables	Association between treatment response and selected clinical and demographic variables collected during the study.	Baseline to Week 24
Incidence of Treatment-Emergent Adverse Events	Safety assessment of topical 2-Deoxy-D-ribose hydrogel based on adverse events, including erythema, itching, pain, allergic or irritant contact dermatitis, and undesirable hair texture, as evaluated through participant history, diary records, and clinical scalp examination.	Baseline to Week 24

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: VEGF; Hair Loss; Male Pattern Hair Loss; Female Pattern Hair Loss; Trichoscopy; 2-Deoxy-D-ribose; 2dDR Hydrogel
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Piperidines; Pyrimidines; Minoxidil; Solutions
• Other Study ID Numbers: MD-390-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No