Evaluating a new hair lotion for treating hair loss

National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Finlândia Hair Lotion Association in the Treatment of Androgenetic Alopecia.

This study is testing a new hair lotion to see if it can help men aged 18 to 60 with hair loss, compared to a standard treatment they’ve been using.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Male
• Sponsor: EMS (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Osasco, São Paulo)
• Trial ID: NCT04594018 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of Finlândia hair lotion in treating androgenetic alopecia in men aged 18 to 60. Participants will be required to have been using minoxidil 5% for at least three months prior to the trial. The study will compare the effects of the Finlândia lotion combined with a placebo against minoxidil combined with finasteride. The trial will focus on participants with specific grades of hair loss as classified by the Norwood-Hamilton scale.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 to 60 with diagnosed androgenetic alopecia grades IIIv to IV who have been using minoxidil 5% for at least three months.

Not a fit: Patients with known hypersensitivity to the trial components or those with other scalp dermatological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective new option for men suffering from androgenetic alopecia.

How similar studies have performed: Other studies have shown success with similar treatments for androgenetic alopecia, indicating potential for this approach.

Eligibility criteria

Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Men aged 18 years or over and less than or equal to 60 years with a diagnosis of Androgenetic Alopecia grades IIIv to IV in the modified Norwood-Hamilton classification, who have been using minoxidil 5% for at least 3 months and willing to maintain the same style, approximate length and hair color throughout the test.

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Participants with other concomitant dermatological diseases on the scalp, except for mild seborrhoea dermatitis;
* Participants with a history of surgical treatment for hair loss or shaved scalp;
* Participants who used shampoo or topical solution containing ketoconazole, tar, selenium, threonine or steroids in the last 2 weeks;
* Participants who used 5α reductase inhibitors, such as finasteride and dutasteride, in the last 12 months;
* Participants using testosterone replacement therapy (TRT) or using testosterone-containing gel;
* Participants who used micro-infusion of medications on the skin (MMP), microneedling or intradermotherapy on the scalp in the last 3 months;
* Participants who have undergone radiation treatment for the scalp or chemotherapy in the past year;
* Participants with diseases that can affect hair growth;
* Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;

Where this trial is running

Osasco, São Paulo

• Medcin Instituto Da Pele — Osasco, São Paulo, Brazil (RECRUITING)

Study contacts

• Study coordinator: Monalisa FB Oliveira, MD

Conditions: Androgenetic Alopecia, androgenetic alopecia