Efficacy of a Combined Oral and Topical Collagen Regimen Compared to Topical Collagen or Oral Collagen Regimens in Women With Skin Ageing Signs

Официальное название

Evaluation of the Efficacy of an in and Out Collagen Routine Versus the Serum Alone and Versus the Oral Supplement Alone in Women With Skin Ageing Signs

Обзор

This clinical study is conducted at one study site and in 165 women with visible signs of skin aging. It compares after 13 weeks the benefit of a combined oral collagen supplement and topical collagen serum regimen compared with oral collagen alone and topical collagen serum alone in reducing in women presenting visible signs of skin ageing .

Вмешательства

• Пищевая добавка Oral collagen
  combination of oral collagen supplementation and topical application of collagen serum
• Другое topical application of collagen serum
  topical application of collagen serum

Первичные конечные точки

• Crow's feet score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep severe wrinkles [Срок оценки: Baseline, Week 3, Week 7, Week 13]

Вторичные конечные точки (12)

• Forhead wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles [Срок оценки: baseline, week 3, week 7, week 13]
• Glabellar's wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles [Срок оценки: baseline, week 3, week 7, week 13]
• Underneath eye wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles [Срок оценки: baseline, week 3, week 7, week 13]
• Nasolabial fold score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no fold to 5=very deep/severe fold [Срок оценки: baseline, week 3, week 7, week 13]
• Upper lip wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep/severe wrinkles [Срок оценки: baseline, week 3, week 7, week 13]
• Wrinkles of the corner of the lip score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep/severe wrinkles [Срок оценки: baseline, week 3, week 7, week 13]
• Ptosis of the lower part of the face on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe fold [Срок оценки: baseline, week 3, week 7, week 13]
• Whole face wrinkles on a scale from 0=no visible wrinkle to 9= very visible wrinkle (clinical visual evaluation by the investigator) [Срок оценки: baseline, week 3, week 7, week 13]
• Skin firmness on a scale from 0=very firm skin to 9= very saggy/not firm skin (clinical tactile evaluation by the investigator) [Срок оценки: baseline, week 3, week 7, week 13]
• Skin elasticity on a scale from 0=very elastic skin to 9= very loose/not elastic skin (clinical tactile evaluation by the investigator) [Срок оценки: baseline, week 3, week 7, week 13]
• Skin tone eveness on a scale from 0=very even skin tone to 9= very even skin tone (clinical visual evaluation by the investigator) [Срок оценки: baseline, week 3, week 7, week 13]
• Skin radiance on a scale from 0=very radiant complexion to 9= uneven complexion/ dull complexion (clinical visual evaluation by the investigator) [Срок оценки: baseline, week 3, week 7, week 13]

Критерии участия

Критерии включения

• Participant having signed an Informed Consent Form (ICF) before any trial related activity is carried out;
• Female participant;
• Participant with a Fitzpatrick skin type I to III;
• Participant aged 45 to 60 years inclusive at the time of signing the ICF;
• Participant with a BMI ≥20 and < 29 kg/m²;
• Participant presenting:
• Cheek firmness score ≥3 and ≤6 on the 10-point scale;
• Crow's feet wrinkle score ≥2 and ≤4 on the L'Oréal Atlas;
• Global facial wrinkle score ≥3 and ≤6 on the 10-point scale.
• Female participant of childbearing potential must use one of the reliable methods of contraception during the investigation and agree not to change it during the study;

A woman is considered of childbearing potential unless she is:

• Postmenopausal for at least 12 months prior to screening visit;
• Without uterus and/or both ovaries;
• Has been surgically sterile for at least 6 months prior to Screening visit.
• Participant must agree to use only the designated products
• Participant willing and able to comply with all study procedures, lifestyle and dietary restrictions, and complete the entire study period
• Participant affiliated to a health social security system (according to French Law).

Критерии исключения

• Participant who is pregnant or who is breast feeding;
• Participant receiving hormone replacement therapy (HRT).
• Participant who smokes more than two cigarettes per week;
• Participant whose alcohol intake exceeds 2 drinks per week;
• Participant with any uncontrolled diseases such as diabetes, hypertension, hyperthyroidism or hypothyroidism;
• Presenting or having a history of eating disorder (e.g. anorexia, food allergy) or gastro-intestinal malabsorption such as celiac disease, Crohn's disease, lactose intolerance;
• Participant with an history of sleeve or bypass;
• Participant with skin abnormalities (e.g., scars, excessive hair, tattooing) or any dermatosis (e.g., psoriasis, eczema, acne vulgaris) on the face which could interfere with the study;
• Participant with history of any severe disease or current condition which, in the opinion of the Investigator would put the participant at risk by participating in the study or would interfere significantly with the evaluation of study results
• Participant with known or suspected hypersensitivity to any ingredient(s) of the investigational products;
• Participants having undergone any aesthetic procedures (such as chemical peels, laser treatments, dermabrasions, injections, anti-ageing masks, hair implants, etc.) on the test areas within 6 months prior to the start of the study are excluded.
• Participant who, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state);
• Participant having use systemic corticosteroids, immunosuppressive drugs, or retinoids (oral or topical) within 3 months prior to study enrollment;
• Only for participants (20 in each group) who are willing to accept skin microbiopsies: The participant who has a contraindication to skin biopsies
• Participant impossible to contact in case of emergency;
• Participant with current participation in any other interventional clinical study, based on interview of the Participant;
• Participant who is in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization;
• Participant who has been deprived of their freedom by administrative or legal decision, or who is under care of a guardian or legal guardianship, or Participant hospitalized in a medical or social establishment for any reason.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07473037 · VCY25-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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