Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-28 @ 10:15 PM
Study NCT ID:
NCT06059534
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2023-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effects of DracoBelle Nu in Skin Health After Oral Intake
Sponsor:
Bionos Biotech S.L.
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Improvement of Skin Health Parameters After Oral Intake of DracoBelle Nu in Human Volunteers
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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) factors. The signs of skin aging include wrinkles, loss of elasticity and firmness, loss of skin density, reduced skin hydration, altered skin barrier effect and alterations in skin pigmentation. Recent studies show that the consumption of nutraceuticals may improve different parameters associated with skin aging. Recently, it has been shown that daily food supplementation with 200 mg of Moldavian dragonhead dry extract (DracoBelleTM Nu) improved the skin hydration, elasticity and increased skin density. In this placebo-controlled study, the investigators aim to investigate the effects of dietary supplementation with DracoBelleTM Nu in different skin parameters associated with age.
The products will be provided in capsules containing placebo or 200 mg of DracoBelleTM Nu. 50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day, preferably in the morning) for 12 weeks. Different parameters will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake. The parameters that will be measured are related to the skin health and skin aging and will be determined as follows:
* The skin elasticity, firmness and fatigue will be measured by the Cutometer in the face skin area.
* Wrinkles (area, length, depth and volume) and roughness of the skin will be measured by the technology Bio3D-MS in the crows-feet and cheek areas.
* The skin density will be measured to determine the thickness of the epidermis and dermis by echography analysis with the UltraScan Echograph in the face skin area.
* Skin hydration will be measured with the Corneometer in the face skin area.
* The skin barrier effect will be measured by quantifying the transepidermal water loss with the Tewameter in the cheek.
* The alterations of the skin pigmentation (area and number of dark spots, and contrast of the dark spots compared to the skin) will be measured with the technology Bio3D-MS.
The products will be provided in capsules containing placebo or 200 mg of DracoBelleTM Nu. 50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day, preferably in the morning) for 12 weeks. Different parameters will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake. The parameters that will be measured are related to the skin health and skin aging and will be determined as follows:
* The skin elasticity, firmness and fatigue will be measured by the Cutometer in the face skin area.
* Wrinkles (area, length, depth and volume) and roughness of the skin will be measured by the technology Bio3D-MS in the crows-feet and cheek areas.
* The skin density will be measured to determine the thickness of the epidermis and dermis by echography analysis with the UltraScan Echograph in the face skin area.
* Skin hydration will be measured with the Corneometer in the face skin area.
* The skin barrier effect will be measured by quantifying the transepidermal water loss with the Tewameter in the cheek.
* The alterations of the skin pigmentation (area and number of dark spots, and contrast of the dark spots compared to the skin) will be measured with the technology Bio3D-MS.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: