Clinical trial NCT03180645: Proof of Concept Anti-ageing Clinical Study in Healthy Subjects
Official title: A Proof of Concept (POC) Clinical Study to Evaluate the Appearance of Fine Lines and Wrinkles on a Developmental Cosmetic Moisturising Cream in Healthy Subjects Presenting Visible Signs of Ageing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 72
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29
timeFrame: At Baseline and Day 29
Secondary outcomes:
measure: Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15
timeFrame: At Baseline and Day 15
measure: Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29
timeFrame: At Baseline, Day 15 and 29
measure: Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29
timeFrame: At Baseline, Day 15 and 29
measure: Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29
timeFrame: At Baseline, Day 15 and 29
measure: Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29
timeFrame: At Baseline, Day 15 and 29
measure: Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29
timeFrame: At Baseline, Day 15 and 29
measure: Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29
timeFrame: At Baseline, Day 15 and 29
measure: Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29
timeFrame: At Baseline and Day 29
measure: Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29
timeFrame: At Baseline, Day 15 and 29
measure: Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29
timeFrame: At Baseline, Day 15 and 29
measure: Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29
timeFrame: At Baseline, Day 15 and 29
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.