Efficacy & Safety of Topical 2-Deoxy-D-ribose Hydrogel Versus Minoxidil 5% Solution in Treatment of Androgenetic Alopecia: A Clinical & Biochemical Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Terminal Hair Density
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Topical 2-Deoxy-D-ribose Hydrogel (Drug)
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.
干预措施: Topical Minoxidil 5% Solution (Drug)
结局指标
主要结局
Change in Terminal Hair Density
时间窗: Baseline to Week 12
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.
Change in Total Hair Density
时间窗: Baseline to Week 12
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.
Change in Tissue VEGF Level
时间窗: Baseline to Week 12
Change in tissue vascular endothelial growth factor (VEGF) levels from baseline to Week 12, measured using scalp biopsy specimens in both treatment groups.
次要结局
- Change in Total Hair Density at Week 24(Baseline to Week 24)
- Global Photographic Assessment(Week 12 and Week 24)
- Patient Global Assessment(Week 12 and Week 24)
- Patient Satisfaction Score(Week 12 and Week 24)
- Incidence of Treatment-Emergent Adverse Events(Baseline to Week 24)
- Correlation of Treatment Response With Clinical and Demographic Variables(Baseline to Week 24)
- Change in Terminal Hair Density at Week 24(Baseline to Week 24)
研究者
heba ahmed abdelgayed ibrahim
Lecturer of Dermatology
Kasr El Aini Hospital