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

ConditionAndrogenic Alopecia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorKasr El Aini Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Topical 2-Deoxy-D-ribose Hydrogel

    Drug

    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.

  • Topical Minoxidil 5% Solution

    Drug

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Topical 2-Deoxy-D-ribose HydrogelExperimental treatment 1 intervention
Group B: Topical Minoxidil 5% SolutionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to Week 12
2

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.

Time frame
Baseline to Week 12
3

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.

Time frame
Baseline to Week 12

Secondary outcomes

1

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.

Time frame
Baseline to Week 24
2

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.

Time frame
Baseline to Week 24
3

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).

Time frame
Week 12 and Week 24
4

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).

Time frame
Week 12 and Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kasr El Aini Hospital

Lead sponsor

Source ClinicalTrials.gov
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