Proof of Concept Anti-ageing Clinical Study in Healthy Subjects

NCT ID: NCT03180645

Last Updated: 2019-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2017-04-21

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.

Detailed Description

Participants who meet all the inclusion/exclusion criteria will be randomised to one of three treatment groups: test product/positive control, test product/no treatment or positive control/no treatment at the baseline visit. Product application within treatment group will be further randomised to either the right or left side of the face. Participants will apply one of the assigned treatments to one side of the face (left or right) and another assigned treatment to the other side of the face as per the randomisation schedule. Participants will be instructed to apply the assigned treatments twice daily (morning and evening, approximately 8-12 hours apart) for 4 weeks (28 days).

Conditions

Skin Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test product/ No treatment

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

Group Type: OTHER

Test product (Moisturising cream)

Intervention Type: 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).

No treatment

Intervention Type: OTHER

No treatment

Test product/ Positive control

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

Group Type: OTHER

Test product (Moisturising cream)

Intervention Type: 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 (Commercial market place moisturising cream)

Intervention Type: 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

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

Group Type: OTHER

Positive control (Commercial market place moisturising cream)

Intervention Type: 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).

No treatment

Intervention Type: OTHER

No treatment

Interventions

Test product (Moisturising cream)

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).

Intervention Type: OTHER

Positive control (Commercial market place moisturising cream)

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).

Intervention Type: OTHER

No treatment

No treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Blepharitis, conjunctivitis, uveitis
• Topical ocular treatment within the last month
• Aesthetic, cosmetic or dermatological treatment on the face within the last 3 months
• Intense sun exposure, Ultra Violet-treatments or tanning salon visit within the last 2 weeks
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit
• Previous participation in this study
• Recent history (within the last 5 years) of alcohol or other substance abuse
• An employee of the sponsor or the study site or members of their immediate family
• A smoker

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

GSK Clinical Trials

Role: STUDY_DIRECTOR

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

Locations

GSK Investigational Site

Schenefeld, Schleswig-Holstein, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 30414275 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

207468

Identifier Type: -

Identifier Source: org_study_id