Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07345195
Eligibility Criteria:
Inclusion criteria:
* Caucasian female volunteers aged 35 to 65 years at the time of signing the Informed Consent Form (ICF).
* Signed Informed Consent Form (ICF).
* Fitzpatrick skin phototypes I-IV.
* Presence of visible signs of skin ageing.
* Presence of visible facial telangiectasias, primarily on the cheeks.
* Presence of facial erythema with a baseline score ≤ 3 on the 5-point Clinical Erythema Assessment (CEA) scale.
* Stable erythema-prone facial skin for at least 3 months prior to study inclusion, without clinical signs of active rosacea.
* In good general health, as determined by medical history.
* Body Mass Index (BMI) \< 35.
* Willingness and ability to:
* Comply with all study procedures and complete a subject diary.
* Maintain usual lifestyle habits throughout the study.
* Not initiate or modify oestrogen or progesterone therapies during the study.
* Maintain the same cosmetic and skincare routine and comply with sun protection guidelines throughout the study.
* Avoid rejuvenation treatments during the study.
* Refrain from consuming food supplements containing collagen or other protein-based supplements, methylsulfonylmethane (MSM), or anti-inflammatory and/or antioxidant compounds with a known or potential impact on skin inflammation or vascular response for the duration of the study.
Exclusion criteria:
* Pregnancy or breastfeeding.
* Vegan diet.
* Heavy smoking or frequent alcohol-induced flushing.
* Occupational or hobby-related excessive heat exposure (e.g. chefs, sauna workers) likely to interfere with vascular stability.
* Anticipated sunbathing or solarium use, or major planned changes in sun exposure before or during the study.
* Planned major changes during the study in:
* Skincare routine
* Hormonal therapy (contraception or hormone replacement therapy)
* Significant changes in dietary habits or dietary supplementation within 3 months prior to inclusion.
* Regular use within 3 months prior to inclusion of food supplements containing:
* Methylsulfonylmethane (MSM);
* Collagen or other protein-based supplements;
* Anti-inflammatory supplements (e.g. bioflavonoids/rutin, curcumin, EPA) and/or antioxidant supplements with a known or potential impact on skin inflammation or vascular response.
* Any diagnosed, uncontrolled, untreated, or unstable medical condition.
* Clinically significant history of metabolic, gastrointestinal, hepatic, renal, or haematological disease.
* Mental incapacity or psychiatric condition that may impair understanding of the study or compliance with study requirements.
* Any clinically significant acute or chronic inflammatory skin disease, including but not limited to acne, perioral dermatitis, psoriasis, atopic dermatitis, or lupus.
* Skin pigmentation disorders at the assessment sites.
* Active rosacea within 3 months prior to study entry, defined as the presence of papules/pustules, frequent flushing episodes typical of rosacea, or ocular involvement.
* Frequent vasomotor hot flushes (e.g. perimenopausal or menopausal), which may interfere with erythema assessments.
* Use of medications affecting skin or vascular reactivity, including but not limited to: systemic corticosteroids, anticoagulants (e.g. coumarins, heparin), vasodilators (e.g. hydralazine, nitroglycerin), antibiotics with potential to affect erythema or vascular response, immunomodulators, regular or long-term use of non-steroidal anti-inflammatory drugs (NSAIDs)
* Use of systemic retinoids within 3 months prior to study entry.
* Changes of skin care routine regimen within 4 weeks prior to study entry.
* Use of highly concentrated topical products (\>15% azelaic acid, 10% vitamin C…) affecting inflammatory or vascular facial responses within 4 weeks prior to study entry.
* Invasive rejuvenation treatments (e.g. medium or deep chemical peels, ablative or vascular laser therapies) within 6 months prior to study entry.
* Non-invasive or minimally invasive rejuvenation treatments (e.g. microneedling, mesotherapy, superficial chemical peels, radiofrequency, electrotherapy, ultrasound, IPL) within 3 months prior to study entry.
* Known or suspected allergy to any ingredient of the investigational product(s).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT07345195
Study Brief:
Protocol Section:
NCT07345195