Proof of Concept Anti-ageing Clinical Study in Healthy Subjects

NCT03180645 | Completed Results

• 1 other identifier: 207468
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this POC clinical study is to evaluate the moisturising effects on fine lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks of twice daily application of the test product on participants presenting visible signs of ageing.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29

  Using fringe projection and optical triangulation techniques, the 3D (three dimensional) surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).

  At Baseline and Day 29

Secondary Outcomes (11)

• Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15

  At Baseline and Day 15

• Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29

  At Baseline, Day 15 and 29

• Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29

  At Baseline, Day 15 and 29

• Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29

  At Baseline, Day 15 and 29

• Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29

  At Baseline, Day 15 and 29

Study Arms (3)

Test product/ No treatment

OTHER

Participants randomized to this arm will apply Test product at allocated sites and leave other sites untreated.

Other: Test product (Moisturising cream); Other: No treatment

Test product/ Positive control

OTHER

Participants randomized to this arm will apply Test and positive product at allocated sites.

Other: Test product (Moisturising cream); Other: Positive control (Commercial market place moisturising cream)

Positive control /No treatment

OTHER

Participants randomized to this arm will apply Positive product at allocated sites and leave other sites untreated.

Other: Positive control (Commercial market place moisturising cream); Other: No treatment

Interventions

Test product (Moisturising cream) OTHER

Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening).

Test product/ No treatment; Test product/ Positive control

Positive control (Commercial market place moisturising cream) OTHER

Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening).

Positive control /No treatment; Test product/ Positive control

No treatment OTHER

No treatment

Positive control /No treatment; Test product/ No treatment

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
• Good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant and relevant abnormalities in medical history or upon physical examination
• Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap \[diaphragm or cervical vault caps\] plus spermicidal agent \[foam, gel, film, cream, suppository\]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that participant
• Willingness to actively participate in the study and to attend all scheduled visits
• Fitzpatrick phototype I-IV
• Visual Clinical Fitzpatrick Wrinkle Score 3- 6 in the eye (crow's feet) area on both sides of the face at screening and baseline
• Subjects with self-reported sensitive skin

You may not qualify if:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
• Women who are breast-feeding
• Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g.diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluations
• Change in contraception within the last 3 months
• Presence of open sores, pimples, cysts, irritated skin, hairs or tattoos at the application site
• Active dermatosis (local or disseminated) that might interfere with the results of the study
• Considered immune compromised
• Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk
• Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit
• Intention of using any oral or topical steroids
• Regular use of inhaled steroids (occasional use is permitted)
• Regular use of topical anti-itch medications (occasional use permitted; the product should be applied with an applicator but not to the proposed application areas
• Use of any topical drug or medication in the proposed application areas
• Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit
• Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

Related Publications (1)

• Nisbet S, Mahalingam H, Gfeller CF, Biggs E, Lucas S, Thompson M, Cargill MR, Moore D, Bielfeldt S. Cosmetic benefit of a biomimetic lamellar cream formulation on barrier function or the appearance of fine lines and wrinkles in randomized proof-of-concept clinical studies. Int J Cosmet Sci. 2019 Feb;41(1):1-11. doi: 10.1111/ics.12499. Epub 2019 Feb 22.

  PMID: 30414275 DERIVED

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: March 20, 2017
• Primary Completion: April 21, 2017
• Study Completion: April 21, 2017
• Last Updated: July 1, 2019
• Results First Posted: July 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)