Status:
COMPLETED
Evaluation of the Effects of DracoBelle Nu in Skin Health After Oral Intake
Lead Sponsor:
Bionos Biotech S.L.
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
35-60 years
Phase:
NA
Brief 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...
Detailed Description
Skin aging refers to the natural process of changes that occur in the skin as individuals get older. It is a complex biological process influenced by both intrinsic (internal) and extrinsic (external)...
Eligibility Criteria
Inclusion
- 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
- 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 weeks prior and during the study.
- Subjects refrain from any intense or invasive cosmetic treatment, alone or by a beautician, such as intense masks, peelings, and other treatments.
- Subjects are free to follow their usual routine of day and night care products.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06059534
Start Date
October 19 2023
End Date
December 30 2023
Last Update
January 18 2024
Active Locations (1)
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1
Bionos Biotech S.L.
Valencia, Spain, 46026