Clinical trial NCT03093181: A Study to Evaluate of Cosmetic Benefit of a Moisturising Cream in People With Blemish Prone Skin
Official title: A Randomized, Parallel-group, Evaluator-blind, No-treatment and Positive Controlled, Single-site, Proof of Concept Clinical Study to Evaluate the Cosmetic Benefit Provided by 8 Weeks of Twice-daily Topical Application of a Developmental Moisturizing Cream With Niacinamide in Healthy Subjects With Sensitive, Oily, Blemish-prone Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the cosmetic benefit provided by twice daily application of a developmental moisturising cream with niacinamide for 8 weeks in healthy female participants with sensitive, oily, blemish-prone skin.

Detailed description: This study broadly consists of two phases: screening / washout phase (5-7 day) followed by treatment phase (approximately of 8 weeks). Participants will be asked to return to the study site 1 week, 4 weeks and 8 weeks after their randomisation visit for instrumental measurements and clinical assessments.

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
* Willingness to actively participate in the study and to attend all scheduled visits
* Minimum of 10 and maximum of 25 blemishes (papules and pustules) at Visit 1 and a minimum of 8 blemishes (papules and pustules) at Visit 2
* Fitzpatrick photo-type I-V
* Sebumeter score of \>66 µg / cm2 at the forehead
* Females of childbearing potential who are, in the opinion of the investigator, practicing 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 participant's entry into the study, and this male is the sole partner for that participant
* Cleanses their face at least once a day

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
* Medical history of using a medicated acne treatment (e.g. Benzoyl Peroxide, Clindamycin, isotretinoin) within the last 12 months
* Change in contraception within the last 3 months
* Active skin disease in the test area
* Medical history of dysplastic nevi or melanoma on the face
* Moles, cysts, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the investigation
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines within 7 days prior to the start of the study and/or throughout the entire course of the study
* Systemic use of anti-microbials within the last month
* Systemic use of over-the-counter (OTC) analgesics or anti-inflammatory drugs 24 hours prior to dosing at the first assessment visit
* One of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
* One of the following illnesses if not medicated: Asthma, hypertension
* Medical history of abnormal response to sunlight
* History of mental illness
* Medically diagnosed acne vulgaris, acne conglobate, fulminans, secondary acne (drug induced acne) or any acne requiring systemic or topical treatment
* No aesthetic, cosmetic or dermatological treatment in the treatment area (face) within the last month
* No intense sun exposure, Ultraviolet-treatments or tanning salon visit within the last 2 weeks
* Known or suspected intolerance, allergy or hypersensitivity to study materials (or closely related compounds) or any of their stated ingredients
* History of allergies to cosmetic products or medicated acne treatments
* Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 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

Primary outcomes:
measure: Change From Baseline in Corneometer Values at 8 Hours on Day 1
timeFrame: At Baseline and Day 1
Secondary outcomes:
measure: Change From Baseline in Corneometer Values at 1 and 3 Hours on Day 1 and at Week 1, 4 and 8
timeFrame: At Baseline, Day 1, Week 1, 4 and 8
measure: Odds for Logistic Regression Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline
timeFrame: At Baseline and Week 8
measure: ANOVA Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline
timeFrame: At Baseline and Week 8
measure: Change From Baseline in Evaluator's Assessment of Total Blemish Count at Week 1, 4, and 8
timeFrame: At Baseline, Week 1, 4 and 8
measure: Change From Baseline in Sebumeter Values at Week 1, 4 and 8
timeFrame: At Baseline, Week 1, 4 and 8
measure: Change From Baseline in Sebum Excretion Rate at Week 1, 4 and 8
timeFrame: At Baseline, Week 1, 4 and 8
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Santos-Caetano JP, Gfeller CF, Mahalingam H, Thompson M, Moore DJ, Vila R, Doi R, Cargill MR. Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomized proof-of-concept study. Int J Cosmet Sci. 2020 Feb;42(1):29-35. doi: 10.1111/ics.12576. Epub 2020 Jan 6.