CompletedNot Applicable

Evaluation of the Effects of DracoBelle Nu in Skin Health After Oral Intake

Spain100 participantsStarted 2023-10-19

Plain-language summary

The goal of this clinical trial is to study the effects of DracoBelleTM Nu in different skin parameters associated with age. Volunteers will be asked to take either placebo of DracoBelleTM Nu capsules once a day by oral intake for a total period of 12 weeks. Several age-associated skin parameters (skin elasticity, firmness, fatigue, wrinkles, roughness, skin density, hydration, pigmentation and barrier effect) will be measured before the treatment and 4, 8 and 12 weeks after the first oral intake. Data of the placebo and DracoBelleTM Nu group will be analyzed to evaluate the effect of the product DracoBelleTM Nu in the selected age-associated skin parameters.

Who can participate

Age range

35 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy female volunteers. * Between 35-60 years old (both included). * With noticeable wrinkles. * Subjects with absence of any infectious disease within the 4 weeks previous to the study. * Informed of the purpose and the protocol of the study and signed a written informed-consent form. Exclusion Criteria: * Diagnosis of any diseases such as cardiovascular disease, chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease. * Consume more than the recommended alcohol guidelines i.e. \>21 alcohol units/week for males and \>14 units/week for females (europa.eu). * Current smoking habit or history of smoking within the past 1 year. * History of depression, schizophrenia, alcoholism, drug addiction, or mental illness. * Current or previous intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants. * History of asthma or autoimmune disease Use of oral hormone therapies ie. cortisone or steroids in the 6 months prior to initiation of the study. * Abnormal liver function or abnormal renal function. * Blood pressure \>140/90 mmHg or hypertension with intake of a diuretic. * Any condition judged by the investigator to be unsuitable for participation in the study. * Subjects refrain from the intake of other oral supplements, including antioxidants, dietary supplements, etc. * Subjects do not alter their mode of contraception 6 we…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

Timeframe: Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

Skin firmness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

Timeframe: Skin firmness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

Skin fatigue will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

Timeframe: Skin fatigue will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

Wrinkles will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

Timeframe: Wrinkles will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

Roughness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

Timeframe: Roughness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

Trial details

NCT IDNCT06059534

SponsorBionos Biotech S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-30

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