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Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women

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ClinicalTrials.gov Identifier: NCT03505684
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Yangsan Hospital

Tracking Information
First Submitted Date  ICMJE April 13, 2018
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date August 28, 2018
Actual Study Start Date  ICMJE December 24, 2017
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
changes in Transepidermal Waterloss by Tewameter [ Time Frame: baseline, after 6 weeks, and after 12 weeks ]
comparison between baseline, after 6 weeks, and after 12 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • changes in skin wrinkling indices by Visiometer [ Time Frame: baseline, after 6 weeks, and after 12 weeks ]
    comparison between baseline, after 6 weeks, and after 12 weeks
  • skin elasticity by Cutometer [ Time Frame: baseline, after 6 weeks, and after 12 weeks ]
    comparison between baseline, after 6 weeks, and after 12 weeks
  • changes in hydration level of the skin surface by Corneometer [ Time Frame: baseline, after 6 weeks, and after 12 weeks ]
    comparison between baseline, after 6 weeks, and after 12 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
Official Title  ICMJE Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
Brief Summary Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants
Detailed Description The aim is to investigate the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants by a randomized, double-blind, and control-group study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Skin Manifestations
  • Skin Wrinkling
Intervention  ICMJE
  • Dietary Supplement: CTP
    1,000 mg of CTP was orally administered per day for 12 weeks.
  • Dietary Supplement: placebo (starch)
    placebo (starch)
Study Arms  ICMJE
  • Experimental: CTP group
    1,000 mg of collagen tripeptide (CTP) was orally administered per day for 12 weeks.
    Intervention: Dietary Supplement: CTP
  • Placebo Comparator: Control group
    1,000 mg of placebo (starch) was orally administered per day for 12 weeks
    Intervention: Dietary Supplement: placebo (starch)
Publications * Tak YJ, Shin DK, Kim AH, Kim JI, Lee YL, Ko HC, Kim YW, Lee SY. Effect of Collagen Tripeptide and Adjusting for Climate Change on Skin Hydration in Middle-Aged Women: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Med (Lausanne). 2021 Jan 11;7:608903. doi: 10.3389/fmed.2020.608903. eCollection 2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2018)
84
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- > = 4 of Tewameter

Exclusion Criteria:

  • Within the last 6 months, took skin surgery including cosmetic purpose
  • Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
  • Creatinine levels: more than twice the normal upper limit
  • AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit
  • Uncontrolled hypertension
  • sun allergy or sensitive skin
  • functional cosmetics that affect dermal moistures and wrinkles within the last 3 months.
  • If you have participated or are planning to participate in another clinical trial within the past month
  • Alcohol abuser
  • If they are pregnant or lactating or have a pregnancy plan during the clinical trial Those with allergic reactions to the constituent food
  • Any person deemed inappropriate by the researcher for other reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03505684
Other Study ID Numbers  ICMJE 02-2017-033
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sang Yeoup Lee, Pusan National University Yangsan Hospital
Study Sponsor  ICMJE Pusan National University Yangsan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sang Yeoup Lee, MD Integrated Research Institute for Natural Ingredients and Functional Foods
PRS Account Pusan National University Yangsan Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP