Last updated: 05/21/2019 09:40:12
Proof of Concept Anti-ageing Clinical Study in Healthy Subjects
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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:
Change from baseline in Ra (a dermaTOP parameter), of test product treated vs. untreated side at Day 15
Timeframe: 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
Timeframe: At Baseline, Day 15 and 29
Change from baseline in Rz (a dermaTOP parameter) at Day 15 and 29
Timeframe: At Baseline, Day 15 and 29
Change from baseline in Sa (dermaTOP parameters) at Day 15 and 29
Timeframe: At Baseline, Day 15 and 29
Change from baseline in Stm (dermaTOP parameters), at Day 15 and 29
Timeframe: At Baseline, Day 15 and 29
Change from baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29
Timeframe: At Baseline, Day 15 and 29
Change from baseline in instrumental corneometer values, at Day 15 and 29
Timeframe: At Baseline, Day 15 and 29
Change from baseline in total proportion of better ranking in texture ranking at Day 29
Timeframe: At Baseline and Day 29
Change from baseline in instrumental cutometer parameters R5, at Day 15 and 29
Timeframe: At Baseline, Day 15 and 29
Change from baseline in instrumental cutometer parameter R7, at Day 15 and 29
Timeframe: At Baseline, Day 15 and 29
Change from baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29
Timeframe: At Baseline, Day 15 and 29
Interventions:
Enrollment:
72
Primary completion date:
2017-21-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Aging
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2017 to April 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female
Age
30 - 65 years
Accepts healthy volunteers
Yes
- 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
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Schenefeld, Schleswig-Holstein, Germany, 22869
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2017-21-04
Actual study completion date
2017-21-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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