Efficacy and Safety of Skin Care Product in Aging Facial Skin

NCT04015063 | Unknown DMC

• 1 other identifier: 201810063RSD
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of P29429-01 as a skin care product to manage skin aging in women subjects 40-65 years of age.

Conditions

Skin Aging

Keywords

Dermatology; Skin Care

Outcome Measures

Primary Outcomes (2)

• Facial skin hydration change from baseline

  Corneum hydration of the skin will be determined using CK's Corneometry

  Week 12

• Facial skin elasticity change from baseline

  Elasticity of the skin will be determined using CK's Cutometer.

  Week 12

Secondary Outcomes (22)

• Facial spots change from baseline

  Week 12

• Facial pores change from baseline

  Week 12

• Facial wrinkles change from baseline

  Week 12

• Facial texture change from baseline

  Week 12

• Facial porphyrin (from Propionibacterium acnes) change from baseline

  Week 12

Study Arms (1)

Primary Subjects

OTHER

Women subjects 40-65 years of age that meet the specified inclusion/exclusion criteria taking P29429-01 as a skin care product per the protocol.

Other: Anti-Aging Skin Care product

Interventions

Anti-Aging Skin Care product OTHER

Primary Subjects will use P29429-01 as an anti-aging skin care product on full face twice a day for 12-week.

Also known as: P29429-01

Primary Subjects

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females 40\~65 years of age;
• Subjects are not found with facial skin tissue changes or inflammation as determined by the investigator ;
• Has skin aging of Glogau class II, i.e. presence of wrinkles during facial movement or resting, as determined by the investigator;
• The subject is able to understand and comply with the requirements, instructions and restrictions specified in the protocol; and
• Sign on the informed consent form.

You may not qualify if:

• Received active facial treatment including laser, pulse light, CPT Thermage, HIFU lifting or subcutaneous filler injection in the last 6 months;
• Has history of chronic skin condition or autoimmune disorders such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea or keloid;
• Has history of allergy to the study skin care product (P29429-01) compositions, moisturizer or sunscreen;
• Pregnant or breastfeeding women;
• Received hormone medications such as estrogen or progesterone, or health foods such as royal jelly, soybean isoflavone, red clover, black cohosh, Chinese Angelica, evening primrose oil, borage oil, chasteberry or placenta extract within 30 days before the study;
• Required treatment for any acute condition or infection within 14 days before the study;
• Experienced a serious medical condition such as disease of the heart, lungs, brain and/or liver within 3 months before the study;
• Has been a routine smoker within 12 months before the study;
• Currently has malignant tumor;
• Has used any medicine for skin use on the face that is deemed to interfere with the study within 30 days before the study by investigator;
• Has participated in another clinical trial within 30 days before the study;
• Receiving medical management that may affect the ability to participate in this study;
• Inappropriate for participating in this study as deemed by the principal investigator.
• Has provided written informed consent for the main study;
• Subjects are not found with tissue changes or inflammation at the planned biopsy site on medial forearm skin as determined by the principal investigator or dermatologist;

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hosptal

Taipei, 100, Taiwan

Location

Related Publications (3)

• Black MM. A modified radiographic method for measuring skin thickness. Br J Dermatol. 1969 Sep;81(9):661-6. doi: 10.1111/j.1365-2133.1969.tb16204.x. No abstract available.

  PMID: 5361423 BACKGROUND

• Uitto J, Fazio MJ, Olsen DR. Molecular mechanisms of cutaneous aging. Age-associated connective tissue alterations in the dermis. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):614-22.

  PMID: 2674224 BACKGROUND

• Melchini A, Catania S, Stancanelli R, Tommasini S, Costa C. Interaction of a functionalized complex of the flavonoid hesperetin with the AhR pathway and CYP1A1 expression: involvement in its protective effects against benzo[a]pyrene-induced oxidative stress in human skin. Cell Biol Toxicol. 2011 Oct;27(5):371-9. doi: 10.1007/s10565-011-9194-6. Epub 2011 Jul 1.

  PMID: 21720915 BACKGROUND

Study Officials

• Yi-Hua Liao, Ph.D

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 10, 2019
• Study Start: March 4, 2019
• Primary Completion: July 5, 2019
• Study Completion: December 13, 2019
• Last Updated: July 10, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)