Improving the efficacy of anti-hair loss drug treatments with a cosmetic lotion containing caffeine, taurine and growth factors

Efficacy and tolerability of a topical formulation based on growth factors, caffeine and taurine in male subjects with androgenetic alopecia who are candidates for pharmacological treatments (topical minoxidil or oral finasteride): A prospective, randomized, assessor-blinded, parallel group study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10404684

Enrollment

Registered

2022-07-18

Start date

2021-01-07

Completion date

Unknown

Last updated

2023-06-13

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

Conditions

Androgenic alopecia in men or women (FAGA) candidate for specific drug treatment (i.e. topical minoxidil in men or women or oral finasteride in men) Skin and Connective Tissue Diseases

Interventions

The study design included 4 treatment arms: 1. Minoxidil 5% twice daily 2. Minoxidil 5% twice daily plus Investigational cosmetic gel (GFM-DA) once weekly 3. Oral Finasteride 1 mg daily 4. Oral Finast

No follow-up A randomisation list was generated by a computer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women >18 years of age 2. Suffering AGA or FAGA requiring drugs treatments (Norwood Hamilton AGA grade III-V)

Exclusion criteria

Exclusion criteria: 1. Inflammatory scalp skin condition 2. AGA treatments (finasteride or minoxidil) in the previous 6 months 3. Iron deficiency anaemia 4. Seborrheic dermatitis or scalp psoriasis

Design outcomes

Primary

Measure	Time frame
1. Evolution of alopecia using a 7-point Global Photographic Assessement Score (GPAS)(+3 Very good improvement,+2 good improvement;+1 mild improvement; 0: not an improvement; -1 mild worsening; -2 worsening; -3 severe worsening) in the group of GFM-DA treated subjects in comparison with the group of drugs treatment only. 2. GPAS was evaluated by comparing the standard photos taken at baseline visit, after 12 weeks and at week 24 by an investigator unaware of treatment arm allocation	—

Measure

Time frame

1. Evolution of alopecia using a 7-point Global Photographic Assessement Score (GPAS)(+3 Very good improvement,+2 good improvement;+1 mild improvement; 0: not an improvement; -1 mild worsening; -2 worsening; -3 severe worsening) in the group of GFM-DA treated subjects in comparison with the group of drugs treatment only. 2. GPAS was evaluated by comparing the standard photos taken at baseline visit, after 12 weeks and at week 24 by an investigator unaware of treatment arm allocation

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026