Last updated: 07/17/2024 17:50:51
To evaluate the effect of moisturizing creams on skin barrier function
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study to Investigate the Effects of Two Developmental Cosmetic Moisturizing Cream Formulations on the Barrier Function of Human Skin on the Face and Legs
Trial description: The aim of this study is to evaluate the impact of twice-daily topical application of two different moisturizing creams on skin barrier function for 4 weeks.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Changes from baseline in TEWL following apllication on face (area 1 compared to area 2) on day 29
Timeframe: At baseline and at day 29
Secondary outcomes:
Changes from baseline in TEWL following application on legs (area 5 compared to area 6) on day 29
Timeframe: At baseline and at day 29
Changes from baseline in TEWL following application on face: area 1 compared to area 2; leg: area 5 compared to area 6) on day 15
Timeframe: At baseline, and at day 15
Changes from baseline in Corneometer values following application on face: area 1 compared to area 2); leg: (area 5 compared to area 6) at 3 different time-points on day 1 and day 2
Timeframe: At baseline, at 30 min on day 1, at 6 hours on day 1, at 24 hours on day 2
Changes from baseline in Corneometer values following application on face (area 1 compared to area 2); leg (area 5 compared to area 6) on day 15 and day 29
Timeframe: At baseline, at day 15, at day 29
Changes from baseline in TEWL following application on face: area 1 compared to area 2; leg: area 5 compared to area 6) on day 30, day 31, day 32, day 33 and day 34
Timeframe: At baseline, at day 30, at day 31, at day 32, at day 33 and at day 34
Changes from baseline in Corneometer values following application on face: area 1 compared to area 2; leg: area 5 compared to area 6) on day 30, day 31, day 32, day 33 and day 34
Timeframe: At baseline, at day 30, at day 31, at day 32, at day 33 and at day 34
Changes from baseline in TEWL following application on face (area 3 compared to area 4); leg (area 7 compared to area 8) at 3 different time points of strips removal (3,6,9 from face and 4,8,12 from legs) on day 29
Timeframe: At day 29 before removal of tape-strips, at day 29 after removal of tape-strips
Total Protein Content extracted from D-Squame discs from a total of 9 adhesive discs on face (area 3 compared to area 4) and a total of 12 adhesive discs on leg (area 7 compared to area 8) on day 29
Timeframe: At day 29
Interventions:
Drug: Developmental moisturizing cream 1
Drug: Developmental moisturizing cream 2
Other: Standard cleanser soap
Enrollment:
158
Observational study model:
Not applicable
Primary completion date:
2019-16-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dry Skin, Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2019 to April 2019
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- 1. Participant provision of a signed and dated informed consent document indicating that the
- 1.A participant who is an employee of the investigational site, either directly involved in the
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. 2. A participant who is willing and able to comply with scheduled visits, the product application schedule, the Lifestyle Considerations, and other study procedures which includes: a) to remove facial make-up at the screening visit to allow visual assessments; b) using other skin-care products is not permitted including but not limited to: leave-on cosmetics, moisturizers, lotions, creams, sunscreens, soaps, cleansing, exfoliation products, etc. on their face or legs, other than the standard soap and study product(s) provided; c) at all post baseline study visit days, participants must cleanse their face and legs with the standard soap and then apply the test product (s) approximately 10-16 hours before each study appointment (i.e. evening before); d) no use of any product on the face or legs, including the standard soap and test product, within 10 hours of all instrumental measurements on visit days (no showering/bathing permitted with soaps/shampoo within this period) will be permitted. 3. A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee (if the investigator is not suitably qualified), no clinically significant/relevant abnormalities in medical history or upon dermatologist examination, or condition, that would impact the participant’s safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual’s ability to understand and follow study procedures and requirements. 4. A participant who responds “Yes” to the following question: Do you consider yourself to have dry, sensitive skin on your face and very dry skin on your legs? 5. A participant with an overall dryness assessment total score of ≥3 for each side of the face at screening visit (Visit 1) and baseline visit (Visit 2). With no more than 0.5-unit score difference between each side of the face. Including an examiner score of at ≥ 1 (slight) for the roughness parameter. 6. A participant with an overall dryness assessment total score of ≥6 for each leg at screening visit (Visit 1) and baseline visit (Visit 2). With no more than 1-unit score difference between each leg. 7. A participant with a Fitzpatrick skin type I-IV.
Exclusion criteria:
- 1.A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family. 2. A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation. 3. A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product application or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. 4. A female participant who is pregnant (self-reported) or intending to become pregnant. 5. A female participant who is breastfeeding. 6. A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 7. A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study. 8. A participant with current or recent (within 6 months before the start of the study) history of atopic lesions and/or eczema. 9. A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients. 10. A participant with any history of significant diseases or medical conditions known to alter skin or eye appearance or physiologic response (e.g. Type 2 diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction. 11. A participant presenting open sores, pimples, or cysts at the application site (face or lower legs). 12. A participant with an active dermatosis (local or disseminated) that might interfere with the results of the study. 13. A participant currently using any medication which in the opinion of the investigator, may affect the evaluation of the investigational product, or place the participant at undue risk 14. A participant who has used any of the following topical or systemic medications up to 1 month before the screening visit or intends to use during the study period: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS), and corticosteroids. 15. A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit or intends to use during the study period. 16. A participant who intends to use any topical drug or medication on the proposed application areas. A participant who has been vaccinated up to 1 month before the screening visit or is intending to receive a vaccination during their participation in the study. 18. A participant currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation 19. A participant with a recent history (within the last 5 years) of alcohol or other substance abuse. 20. A participant with any skin marks on the face or lower legs that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles). 21. Participants with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperemia or other active ocular diseases. 22. A participant who has previously been enrolled in this study. 23. A participant who is unwilling to abstain from smoking tobacco or using any other nicotine containing products. 24. A participant with visible sunburn on any of the test sites. 25. A participant with moles, tattoos, scars, hairs, etc. at the test areas if it is likely that they could affect the assessments. 26. A participant who has used self-tanning products on the test areas (face and arms) within 2 weeks prior to the screening visit. 27. A participant who intends to expose their skin to natural or artificial ultraviolet (UV) light (e.g. sunbathing or tanning beds). 28. A participant with any participant self-assessed or dermatologist dryness parameter score 4 (very severe) on the test areas of the lower legs or face. 29. Any participant who, in the judgment of the Investigator, should not participate in the study.
Trial location(s)
Location
GSK Investigational Site
Schenefeld, Schleswig-Holstein, Germany, 22869
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
Completed
Actual primary completion date
2019-16-04
Actual study completion date
2019-16-04
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website