A Clinical Trial to Evaluate the Effects of Naila's Collagen Marine Plus Food Supplement on Skin Hydration, Elasticity, Fine Lines and Wrinkles, and Hair and Nail Health

Обзор

This is a single-group, open-label, virtual (decentralized) clinical trial evaluating the effects of Naila's Collagen Marine Plus Food Supplement on skin hydration, elasticity, firmness, fine lines and wrinkles, and hair and nail health over 12 weeks. Forty healthy adults aged 40-60 years with self-reported mature skin showing early signs of aging will take one sachet of the supplement daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Participants will also submit standardized facial and hair photographs at Baseline and Week 12 for evaluation by a board-certified dermatologist. The primary objectives are to assess changes in skin aging parameters and hair health. Secondary objectives include evaluation of nail health, hair shedding and density, participant-reported satisfaction, and product safety and tolerability.

Вмешательства

• Пищевая добавка Naila's Collagen Marine Plus Food Supplement
  All 40 participants receive Naila's Collagen Marine Plus Food Supplement (one sachet daily, dissolved in approximately 200 mL of water, taken once daily in the morning) for 12 weeks.

Первичные конечные точки

• Change in Self-Reported Skin Hydration [Срок оценки: Baseline to Week 12]
• Change in Self-Reported Skin Elasticity [Срок оценки: Baseline to Week 12]
• Change in Self-Reported Skin Firmness [Срок оценки: Baseline to Week 12]
• Change in Self-Reported Fine Lines and Wrinkles [Срок оценки: Baseline to Week 12]
• Change in Dermatologist-Graded Fine Line and Wrinkle Severity [Срок оценки: Baseline to Week 12]
• Change in Dermatologist-Graded Skin Firmness [Срок оценки: Baseline to Week 12]
• Change in Dermatologist-Graded Overall Skin Quality [Срок оценки: Baseline to Week 12]
• Change in Dermatologist-Graded Hair Parameters [Срок оценки: Baseline to Week 12]

Вторичные конечные точки (8)

• Change in Self-Reported Nail Strength [Срок оценки: Baseline to Week 12]
• Change in Self-Reported Nail Brittleness [Срок оценки: Baseline to Week 12]
• Change in Self-Reported Nail Growth Rate [Срок оценки: Baseline to Week 12]
• Change in Self-Reported Overall Nail Appearance [Срок оценки: Baseline to Week 12]
• Change in Self-Reported Hair Shedding [Срок оценки: Baseline to Week 12]
• Change in Self-Reported Hair Thickness and Density [Срок оценки: Baseline to Week 12]
• Participant-Reported Product Satisfaction and Perceived Global Improvement [Срок оценки: Week 12]
• Incidence of Adverse Events [Срок оценки: Baseline through Week 12]

Критерии участия

Критерии включения

• Healthy adults aged 40-60 years at the time of enrollment.
• Self-reported visible signs of skin aging, including at least one of the following: fine lines, wrinkles, reduced skin firmness or elasticity, or skin dryness.
• Self-reports hair shedding and a desire to improve hair health.
• Willing to take one sachet of the study product daily for 12 weeks as directed.
• Willing to avoid taking any other collagen-containing dietary supplements for the duration of the study.
• Willing to maintain current diet, skincare routine, sleep patterns, and physical activity levels for the duration of the trial.
• Willing and able to submit standardized facial and hair photographs at Baseline and Week 12.
• Has access to a smartphone or digital camera capable of producing photographs.
• Resides in the United States.
• Willing to follow the study protocol and complete all required questionnaires.

Критерии исключения

• Known allergy or sensitivity to fish, marine-derived products, or any of the study product ingredients (marine collagen, hyaluronic acid, ascorbic acid, biotin).
• Previous diagnosis of a hair loss condition such as alopecia areata, androgenetic alopecia, or telogen effluvium.
• Currently taking any collagen-containing dietary supplements, or planning to start taking any collagen supplements in the next 12 weeks.
• Any current uncontrolled chronic medical condition that would prevent the participant from safely completing the study protocol.
• History of a diagnosed dermatological condition that significantly affects facial skin appearance (e.g., severe eczema, psoriasis, rosacea, or active acne) and could confound assessment of skin aging outcomes.
• Use of prescription retinoids, injectable dermal fillers, botulinum toxin, chemical peels, laser skin treatments, or other professional aesthetic procedures on the face within 3 months prior to enrollment or planned during the study period.
• Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
• Currently participating in another research study or planning to participate in another study during this study's duration.
• Any condition that, in the judgment of the investigator, would make the participant unsuitable for inclusion in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07746076 · GULFB-52447

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗