Placebo Controlled Efficacy Evaluation of the Hydrolyzed Collagen Peptide In Adult Females

This is an interventional supportive care trial for Skin Read More

Inclusion Criteria:

• Female volunteers aged between 35 and 60 years,
• Volunteers who have normal physical examination at screening visit,
• Volunteers who have ability to communicate adequately with the investigator and in agreement to comply with the study requirements,
• Volunteers who have normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 100 bpm at least after 5 minutes of rest,
• Volunteers who have understanding of the study and agreement to give a written informed consent.

Exclusion Criteria:

• Who have atopic constitution or asthma and/or known allergy for biosynthetic collagen products and/or other any of the excipients of the product.
• Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
• Who have the use of oral retinoids or oral steroids in the 6 months prior to initiation of the study.
• Who have the use of topical retinoids, anti-wrinkle cosmetic products including retinol and/or AHA, or moisture-rich cosmetic products within the 3 months prior to initiation of the study.
• Who use skincare therapy using lasers or peeling within the 3 months prior to initiation of the study.
• Who have current participation in another clinical study, or participation in any type of dermatology study within 3 months.
• Who have any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphiria.
• Who have the presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
• Who had undergone, or planned to undergo, pregnancy or breastfeeding.
• Who have current intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants.
• Who are suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgment.
• Who have history of drug abuse.
• Who have relationship to the investigator.
• Who are not suitable to any of inclusion criteria.
• Who have history of difficulty of swallowing.
• Who are on a special diet due to any reason, or, have gained or lost 5% of baseline weight.