Fine Lines and Wrinkles, Hair Health, Nail Health, Skin Aging, Skin Elasticity, Skin Hydration
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNaila'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.
Sponsors
Gulf Bird
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Skin Hydration | Baseline to Week 12 | Mean change from Baseline in self-reported skin hydration assessed via self-reported questionnaire |
| Change in Self-Reported Skin Elasticity | Baseline to Week 12 | Mean change from Baseline in self-reported skin elasticity assessed via self-reported questionnaire |
| Change in Self-Reported Skin Firmness | Baseline to Week 12 | Mean change from Baseline in self-reported skin firmness assessed via self-reported questionnaire |
| Change in Self-Reported Fine Lines and Wrinkles | Baseline to Week 12 | Mean change from Baseline in self-reported appearance of fine lines and wrinkles assessed via self-reported questionnaire |
| Change in Dermatologist-Graded Fine Line and Wrinkle Severity | Baseline to Week 12 | Mean change from Baseline in fine line and wrinkle severity assessed by dermatologist review of standardized facial photographs |
| Change in Dermatologist-Graded Skin Firmness | Baseline to Week 12 | Mean change from Baseline in skin firmness assessed by dermatologist review of standardized facial photographs |
| Change in Dermatologist-Graded Overall Skin Quality | Baseline to Week 12 | Mean change from Baseline in overall skin quality assessed by dermatologist review of standardized facial photographs |
| Change in Dermatologist-Graded Hair Parameters | Baseline to Week 12 | Mean change from Baseline in hair health parameters assessed by dermatologist review of standardized hair photographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Nail Strength | Baseline to Week 12 | Mean change from Baseline in self-reported nail strength assessed via self-reported questionnaire |
| Change in Self-Reported Nail Brittleness | Baseline to Week 12 | Mean change from Baseline in self-reported nail brittleness assessed via self-reported questionnaire |
| Change in Self-Reported Nail Growth Rate | Baseline to Week 12 | Mean change from Baseline in self-reported nail growth rate assessed via self-reported questionnaire |
| Change in Self-Reported Overall Nail Appearance | Baseline to Week 12 | Mean change from Baseline in self-reported overall nail appearance assessed via self-reported questionnaire |
| Change in Self-Reported Hair Shedding | Baseline to Week 12 | Mean change from Baseline in self-reported hair shedding assessed via self-reported questionnaire |
| Change in Self-Reported Hair Thickness and Density | Baseline to Week 12 | Mean change from Baseline in self-reported hair thickness and density assessed via self-reported questionnaire |
| Participant-Reported Product Satisfaction and Perceived Global Improvement | Week 12 | Participant-reported satisfaction and perceived global improvement assessed via self-reported questionnaire at Week 12 |
| Incidence of Adverse Events | Baseline through Week 12 | Number and severity of adverse events reported by participants throughout the 12-week study period, assessed via study questionnaires and reviewed by the study team |
Contacts
CONTACTPatrick Renner
Outcome results
None listed