Hair and Scalp Health, Hair Loss, Skin Aging
Conditions
Keywords
Skin Health, Hair Health, Antioxidant Capacity
Brief summary
The goal of this clinical trial is to learn whether daily intake of CyanthOx™80 capsules can improve skin, scalp, hair, and selected blood biomarkers in healthy adults after 12 weeks. Researchers will compare participants who take CyanthOx™80 with participants who take a placebo to evaluate its effectiveness and tolerability. A total of 40 participants will be randomly assigned to the CyanthOx™80 group or placebo group, with 20 participants in each group. Participants will not know which capsule they receive. Participants will: Take one capsule daily for 12 weeks. Attend study visits at baseline and weeks 4, 8, and 12. Undergo non-invasive facial skin assessments at baseline, week 4, and week 12. Undergo scalp and hair assessments at baseline and weeks 4, 8, and 12. Provide a 10 mL blood sample at baseline and week 12 for tests related to antioxidant capacity, inflammation, aging, collagen, and blood lipids. Complete questionnaires about skin condition and product satisfaction. Provide collected shed hair at weeks 4, 8, and 12. Have facial, scalp, and hair photographs taken. Identifiable areas will be masked before disclosure. Before each skin or scalp assessment, participants will cleanse the test area with water and rest at room temperature for 30 minutes.
Interventions
DIETARY_SUPPLEMENTPlacebo Group
Participants will take one placebo capsule daily for 12 weeks.
DIETARY_SUPPLEMENTCyanthOx™80 Group
Participants will take one CyanthOx™80 capsule daily for 12 weeks.
Sponsors
Chia Nan University of Pharmacy ＆ Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants aged over 18 years.
Exclusion criteria
* Individuals who are unwilling to participate voluntarily. * Individuals diagnosed by a physician with skin disease, liver cirrhosis, or chronic renal failure. * Individuals with known allergies to cosmetics, drugs, or foods. * Pregnant or breastfeeding individuals. * Individuals taking medications for chronic diseases. * Students taught by the principal investigator. * Individuals unwilling to allow their study-related photographs to be disclosed. Vegetarians.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product Tolerability | Baseline to Week 12 | Product tolerability will be assessed by recording any adverse events reported by participants during the study. The number and percentage of participants experiencing one or more adverse events will be summarized for each group. unit： number and percentage of participants |
| Participant-Reported Skin Condition and Product Satisfaction | Baseline, Week 4, and Week 12 | Perceived skin condition and product satisfaction will be assessed using a study-specific questionnaire with a 5-point scale, ranging from 1 to 5. Higher scores indicate greater perceived improvement or satisfaction. The percentage of participants with a score of 3 or higher will be reported. Unit：score |
| Change in Blood Biomarkers (TEAC) | Baseline and Week 12 | Changes in biomarkers related to antioxidant capacity using TEAC ELISA kits. Unit: percent change |
| Change in Hair and Scalp Condition (hair-root diameter) | Baseline, Week 4, Week 8, and Week 12 | Changes in hair-root diameter by using Mitutoyo, C/N293-100 Unit：percent change |
| Change in Hair and Scalp Condition (hair strength) | Baseline, Week 4, Week 8, and Week 12 | Changes in hair strength by using Hair Pull Test Unit：percent change |
| Change in Hair and Scalp Condition (hair elasticity) | Baseline, Week 4, Week 8, and Week 12 | Changes in hair elasticity measured using SHIMADZU EZ-SX Unit：percent change |
| Change in Hair and Scalp Condition (tensile strength) | Baseline, Week 4, Week 8, and Week 12 | Changes in tensile strength by using SHIMADZU EZ-SX Unit：percent change |
| Change in Hair and Scalp Condition (hair shedding) | Baseline, Week 4, Week 8, and Week 12 | Changes in hair shedding by collecting and counting hairs found in the shower drain unit：percent change |
| Change in Blood Biomarkers (SOD) | Baseline and Week 12 | Changes in biomarkers related to antioxidant capacity measured using SOD ELISA kits. Unit: percent change |
| Change in Blood Biomarkers (GSH) | Baseline and Week 12 | Changes in biomarkers related to antioxidant capacity using GSH ELISA kits. Unit: percent change |
| Change in Blood Biomarkers (TNF-alpha) | Baseline and Week 12 | Changes in biomarkers related to inflammation measured using TNF-alpha ELISA kits. Unit: percent change |
| Change in Blood Biomarkers (Desmosine) | Baseline and Week 12 | Changes in biomarkers related to aging measured using Desmosine ELISA kits. Unit: percent change |
| Change in Blood Biomarkers (AGE) | Baseline and Week 12 | Changes in biomarkers related to aging measured using AGE ELISA kits. Unit: percent change |
| Change in Blood Biomarkers (HA) | Baseline and Week 12 | Changes in biomarkers related to collagen metabolism measured using TEAC HA kits. Unit: percent change |
| Change in Blood Biomarkers (NAD/NADH) | Baseline and Week 12 | Changes in biomarkers related to antioxidant capacity measured using NAD/NADH ELISA kits. Unit: percent change |
| Change in Blood Biomarkers (Collagen) | Baseline and Week 12 | Changes in biomarkers related to collagen metabolism measured using Collagen ELISA kits. Unit: percent change |
| Change in Blood Biomarkers (Telomerase) | Baseline and Week 12 | Changes in biomarkers related to aging, measured using Telomerase ELISA kits. Unit: percent change |
| Change in Blood Biomarkers (CHOL) | Baseline and Week 12 | Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change |
| Change in Blood Biomarkers (TG) | Baseline and Week 12 | Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change |
| Change in Blood Biomarkers (HDL) | Baseline and Week 12 | Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change |
| Change in Blood Biomarkers (LDL) | Baseline and Week 12 | Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change |
| Facial Skin Analysis Parameters (skin spots) | Baseline, Week 4, and Week 12 | VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin spots. Units: percetage change. |
| Facial Skin Analysis Parameters (Wrinkle) | Baseline, Week 4, and Week 12 | VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Wrinkle. Units: percetage change. |
| Facial Skin Analysis Parameters (Texture) | Baseline, Week 4, and Week 12 | VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Texture. Units: percetage change. |
| Facial Skin Analysis Parameters (Spot) | Baseline, Week 4, and Week 12 | VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Spot. Units: percetage change. |
| Facial Skin Analysis Parameters (UV Spot) | Baseline, Week 4, and Week 12 | VISIA Micro-Analysis Skin Image Analyzer was utilized to measure UV Spot. Units: percetage change. |
| Facial Skin Analysis Parameters (Brown Spot) | Baseline, Week 4, and Week 12 | VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Brown Spot. Units: percetage change. |
| Facial Skin Analysis Parameters (Red Area) | Baseline, Week 4, and Week 12 | VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Red Area. Units: percetage change. |
| Facial Skin Analysis Parameters (Collagen) | Baseline, Week 4, and Week 12 | DermaLab® Series SkinLab Combo was utilized to measure collagen. Units: percetage change. |
| Facial Skin Analysis Parameters (Brightness) | Baseline, Week 4, and Week 12 | Chroma Meter MM500 was utilized to measure Brightness. Units: percetage change. |
| Facial Skin Analysis Parameters (Erythema) | Baseline, Week 4, and Week 12 | Chroma Meter MM500 was utilized to measure Erythema. Units: percetage change. |
| Facial Skin Analysis Parameters (Melanin) | Baseline, Week 4, and Week 12 | Soft Plus was utilized to measure Melanin. Units: percetage change. |
| Facial Skin Analysis Parameters (Skin Hydration) | Baseline, Week 4, and Week 12 | Corneometer CM825 was utilized to measure Skin Hydration. Units: percetage change. |
| Facial Skin Analysis Parameters (Skin Elasticity) | Baseline, Week 4, and Week 12 | Soft Plus was utilized to measure Skin Elasticity. Units: percetage change. |
| Facial Skin Analysis Parameters (Transepidermal Water Loss) | Baseline, Week 4, and Week 12 | Tewameter TM300 was utilized to measure Transepidermal Water Loss. Units: percetage change. |
Countries
Taiwan
Outcome results
None listed