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Real-world effectiveness and safety of topical finasteride combined with minoxidil versus oral finasteride combined with minoxidil in the treatment of androgenetic alopecia: a single-center prospective cohort study

Real-world effectiveness and safety of topical finasteride combined with minoxidil versus oral finasteride combined with minoxidil in the treatment of androgenetic alopecia: a single-center prospective cohort study - TOF-AGA Study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119739
Enrollment
Unknown
Registered
2026-03-03
Start date
2026-03-03
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic alopecia

Interventions

Topical Treatment Group:None
Oral Treatment Group:None

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Male, 18 to 55 years of age, inclusive; 2. Confirmed diagnosis of AGA, classified as Grade III-vertex, IV, or V according to the Hamilton-Norwood scale; 3. Having standardized global scalp photography and trichoscopic data available at baseline; capable of completing the 12-week and 24-week follow-up visits; having complete medical records and contact details; and demonstrating compliance with follow-up and data recording requirements; 4. For the prospective cohort, signed written informed consent must be obtained at baseline.

Exclusion criteria

Exclusion criteria: 1. Severe Comorbidities or Surgeries: Any uncontrolled severe systemic disease or recently unstable condition (e.g., cardiovascular, neurological, hematological, gastrointestinal, immunological, or psychiatric disorders) that may affect medication safety or outcome evaluation; or a history of major surgery within 3 months prior to baseline, or a planned major surgery during the study period; 2. Concurrent Other Types of Alopecia: Known concurrent presence of other types of hair loss, such as telogen effluvium, alopecia areata, syphilitic alopecia, scarring alopecia, or alopecia induced by malnutrition, chemotherapy, or radiotherapy; 3. Scalp Diseases or Injuries Affecting Evaluation: Any scalp disease or lesion that may interfere with efficacy evaluation, including fungal/bacterial infections, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis, scalp atrophy, or significant trauma; 4. Other Conditions Affecting Hair Growth: Systemic conditions that significantly affect hair growth or its evaluation (e.g., connective tissue diseases, active inflammatory bowel disease, moderate-to-severe anemia, or significant short-term weight loss); 5. Hair Transplantation and Cosmetic Interferences: A history of hair transplantation within the past 12 months; or the requirement to wear a wig/hairpiece long-term or use hair styling products (e.g., hairspray) during the study period, which may interfere with objective evaluation; 6. Medication Exposure and Treatments Potentially Interfering with Efficacy: Topical application of medications on the hair loss area for >= 14 consecutive days within 6 months prior to baseline that may interfere with evaluation (e.g., corticosteroids, minoxidil, or medicated shampoos/solutions containing ketoconazole or similar active ingredients); Systemic use of medications within 6 months prior to baseline that may affect outcomes (e.g., corticosteroids, immunosuppressants, chemotherapy, or cytotoxic drugs); Use of finasteride or other 5a-reductase inhibitors (including oral or topical formulations) within 6 months prior to baseline; Receipt of autologous platelet-rich plasma (PRP) therapy, microneedling, or low-level laser therapy (LLLT) within 6 months prior to baseline; 7. Allergy or Intolerance: Hypersensitivity or intolerance to finasteride, minoxidil, or any of their excipients; 8. Family Planning: Having reproductive/family planning intentions during the study period; 9. Investigator Discretion: Any other conditions that, in the opinion of the investigator, may affect medication adherence or render the subject unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Hair count (tahc) change;

Secondary

MeasureTime frame
Norwood-Hamilton Scale;Hair count (tahc) change;Variation of hair shaft diameter (tahw);Change in the ratio of terminal hair / pili + intermediate hair;Change of hair follicle proportion of single hair;

Countries

China

Contacts

Public ContactHsiaoHan Tuan

Beijing Tsinghua Changgung Hospital

dxha00337@btch.edu.cn+86 186 1001 5166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026