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NCT Number: NCT06590779

Benefits of a Cosmetic Anti-hair Loss in Males With Hair Loss

Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. AGA is a polygenetic condition with varying severity, age of onset, and scalp location of hair loss. In men, hair loss typically involves the temporal and vertex region while sparing the occipital region: the characteristic "horseshoe" pattern. Incidence and prevalence of AGA depend on age and race.

Vichy has developed a new cosmetic anti hair loss lotion with the aim of acting on androgenic alopecia. The aim is to improve the efficacy on hair loss of the association of the lotion with finasteride versus finasteride alone.

The primary objective of this investigator-blinded, randomized multi-center study is to quantitatively evaluate, using the phototrichogram method, the efficacy of a lotion associated with finasteride versus finasteride alone on hair growth parameters in male subjects with androgenetic alopecia.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subject aged 18-41 years old with skin type I to IV according to the Fitzpatrick scale;
  • Affected by androgenetic alopecia with hair loss evaluated grade IIA to IV the modified Norwood-Hamilton scale;
  • Subject with chestnut brown, dark or black hair;
  • Subject with hair length ≥ 3 cm on the vertex and agreeing to keep this minimum length for the duration of the study;
  • Subject agreeing to have a shaved zone of 1.5 cm² on scalp area;
  • Subject accepting not to dye, bleach his hair or to do a permanent wave during the whole study duration;
  • Subject accepting to use condoms if her partner is pregnant.

Exclusion criteria

  • Female subject;
  • Subject presenting a life-threatening endocrine disease, neoplasia or other serious diseases;
  • Subjects suffering from chemo-induced alopecia (poisoning, medicines), or resulting from a chronic disease (genetic, endocrine, immunological, deficiencies), seasonal hair loss;
  • Subject having any other concomitant dermatological affection of the scalp (psoriasis, seborrheic dermatitis, eczema, other alopecia than androgenetic);
  • Subject suffering from a recurrent, acute, non-stabilized or evolving disease judged by the investigator able to interfere with the study needs and hair growth;
  • Subject having had surgical intervention for capillary correction (e.g., hair transplant) or intending to have recourse to this surgery during the entire study period;
  • Subject presenting a hypersensitivity to any of the components of the finasteride medication or to any 5-alpha-reductase inhibitor;
  • Subject that has applied or taken prior to the start of the study (screening) interfering drugs or products
  • Subject taking any other medical treatment (topic or per os) likely to interfere on hair growth or hair loss within 6 months prior to the screening visit;
  • Subject following a long period (>30 days) treatment of anti-inflammatory within 4 months prior to the start of the study (screening visit);
  • Subject taking topic cosmetic treatment or per os nutritional supplement likely to interfere on hair growth or hair loss during the last 3 months prior to the screening visit;
  • Subject having a topical or oral route treatment of the scalp (anti-seborrheic, anti-dandruff, daily friction) within 2 weeks prior to the screening visit;
  • Subject who has been exposed within one month prior to the screening visit in an intense or excessive manner to sun (natural or artificial) or during the study;
  • Subject having a wig or hair extension;
  • Protected subject as defined in the Articles of the French Public Health Code. Article 1121-7: person deprived of liberty by a judicial or administrative decision, or subject to psychiatric care, or person admitted to a health or social institution for purposes other than the research. Article 1121-8: adult person subject to a legal protection measure or unable to express his/her consent;
  • Subject unable to communicate or cooperate with the Investigator due to poor mental development, language problems or impaired cerebral function;
  • Subject currently participating in another clinical study or being in an exclusion period of another clinical study;

Treatment and study plan

Aminexil® active+ lotion

Other

Aminexil® active+ lotion

Finasteride 1mg

Other

Finasteride 1 mg

Primary outcomes

  1. Phototrichogram

    Time frame: baseline T0

    photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  2. Phototrichogram

    Time frame: Day 3

    photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  3. Phototrichogram

    Time frame: Day 84

    photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  4. Phototrichogram

    Time frame: Day 86

    photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  5. Phototrichogram

    Time frame: Day 168

    photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  6. Phototrichogram

    Time frame: Day 170

    photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  7. Phototrichogram

    Time frame: Day 336

    photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  8. Phototrichogram

    Time frame: Day 338

    photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

Secondary outcomes

  1. Scalp coverage evaluation

    Time frame: baseline Day 1

    on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible

  2. Scalp coverage evaluation

    Time frame: Day 84

    on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible

  3. Scalp coverage evaluation

    Time frame: Day 168

    on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible

  4. Scalp coverage evaluation

    Time frame: Day 336

    on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible

  5. Subject Evaluation on Vertex and Frontal Area of hair quality

    Time frame: baseline Day 1

    scale from -3: greatly decreased to 3: greatly increased

  6. Subject Evaluation on Vertex and Frontal Area of hair quality

    Time frame: Day 84

    scale from -3: greatly decreased to 3: greatly increased

  7. Subject Evaluation on Vertex and Frontal Area of hair quality

    Time frame: Day 168

    scale from -3: greatly decreased to 3: greatly increased

  8. Subject Evaluation on Vertex and Frontal Area of hair quality

    Time frame: Day 252

    scale from -3: greatly decreased to 3: greatly increased

  9. Subject Evaluation on Vertex and Frontal Area of hair quality

    Time frame: Day 336

    scale from -3: greatly decreased to 3: greatly increased

  10. Quality of life assessment

    Time frame: baseline Day 1

    Non-validated 13-point questionnaire; point 1-6: on a 5 point scale from never to always point 7-13 on a 5-point scale from totally agree to not agree at all

  11. Quality of life assessment

    Time frame: Day 84

    Non-validated 13-point questionnaire; point 1-6: on a 5 point scale from never to always point 7-13 on a 5-point scale from totally agree to not agree at all

  12. Quality of life assessment

    Time frame: Day 168

    Non-validated 13-point questionnaire; point 1-6: on a 5 point scale from never to always point 7-13 on a 5-point scale from totally agree to not agree at all

  13. Quality of life assessment

    Time frame: Day 336

    Non-validated 13-point questionnaire; point 1-6: on a 5 point scale from never to always point 7-13 on a 5-point scale from totally agree to not agree at all

  14. Local discomfort

    Time frame: baseline Day 1

    scale from 0: none to 9: hugely

  15. Local discomfort

    Time frame: Day 84

    scale from 0: none to 9: hugely

  16. Local discomfort

    Time frame: Day 168

    scale from 0: none to 9: hugely

  17. Local discomfort

    Time frame: Day 336

    scale from 0: none to 9: hugely

  18. Local reactions

    Time frame: baseline Day 1

    scale from 0: none to 4: very severe

  19. Local reactions

    Time frame: Day 84

    scale from 0: none to 4: very severe

  20. Local reactions

    Time frame: Day 168

    scale from 0: none to 4: very severe

  21. Local reactions

    Time frame: Day 336

    scale from 0: none to 4: very severe

  22. Adverse events

    Time frame: baseline Day 1

    Questioning

  23. Adverse events

    Time frame: baseline Day 3

    Questioning

  24. Adverse events

    Time frame: Day 42

    Questioning

  25. Adverse events

    Time frame: Day 84

    Questioning

  26. Adverse events

    Time frame: Day 86

    Questioning

  27. Adverse events

    Time frame: Day 126

    Questioning

  28. Adverse events

    Time frame: Day 168

    Questioning

  29. Adverse events

    Time frame: Day 170

    Questioning

  30. Adverse events

    Time frame: Day 210

    Questioning

  31. Adverse events

    Time frame: Day 252

    Questioning

  32. Adverse events

    Time frame: Day 294

    Questioning

  33. Adverse events

    Time frame: Day 336

    Questioning

  34. Adverse events

    Time frame: Day 338

    Questioning

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Faure

CONTACT

[email protected]

33049643274

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Collaborators

  • Centre Hospitalier Universitaire de Nice
  • Saint-Louis Hospital, Paris, France

Registry information

Official study title

Evaluation of the Benefits of a Cosmetic Anti-hair Loss Lotion Applied in Combination With Finasteride in Male Subjects With Hair Loss: Investigator-blinded, Randomized, Multi-center Study Performed Under Dermatological Control

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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