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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Aminexil® active+ lotion
  Aminexil® active+ lotion
• Другое Finasteride 1mg
  Finasteride 1 mg

Первичные конечные точки

• Phototrichogram [Срок оценки: baseline T0]
• Phototrichogram [Срок оценки: Day 3]
• Phototrichogram [Срок оценки: Day 84]
• Phototrichogram [Срок оценки: Day 86]
• Phototrichogram [Срок оценки: Day 168]
• Phototrichogram [Срок оценки: Day 170]
• Phototrichogram [Срок оценки: Day 336]
• Phototrichogram [Срок оценки: Day 338]

Вторичные конечные точки (12)

• Scalp coverage evaluation [Срок оценки: baseline Day 1]
• Scalp coverage evaluation [Срок оценки: Day 84]
• Scalp coverage evaluation [Срок оценки: Day 168]
• Scalp coverage evaluation [Срок оценки: Day 336]
• Subject Evaluation on Vertex and Frontal Area of hair quality [Срок оценки: baseline Day 1]
• Subject Evaluation on Vertex and Frontal Area of hair quality [Срок оценки: Day 84]
• Subject Evaluation on Vertex and Frontal Area of hair quality [Срок оценки: Day 168]
• Subject Evaluation on Vertex and Frontal Area of hair quality [Срок оценки: Day 252]
• Subject Evaluation on Vertex and Frontal Area of hair quality [Срок оценки: Day 336]
• Quality of life assessment [Срок оценки: baseline Day 1]
• Quality of life assessment [Срок оценки: Day 84]
• Quality of life assessment [Срок оценки: Day 168]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06590779 · VCY23-015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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