A Study to Evaluate of Cosmetic Benefit of a Moisturising Cream in People With Blemish Prone Skin

NCT03093181 | Completed Results

• 1 other identifier: 207196
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Care

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Corneometer Values at 8 Hours on Day 1

  A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturization.Measurement of skin moisturization was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content.The range of hydration level was 0 (as dry as possible)\~120 AU (Arbitrary Unit)(most moist possible).Higher Corneometer values are indicative of improved skin moisturization.

  At Baseline and Day 1

Secondary Outcomes (6)

• Change From Baseline in Corneometer Values at 1 and 3 Hours on Day 1 and at Week 1, 4 and 8

  At Baseline, Day 1, Week 1, 4 and 8

• Odds for Logistic Regression Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline

  At Baseline and Week 8

• ANOVA Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline

  At Baseline and Week 8

• Change From Baseline in Evaluator's Assessment of Total Blemish Count at Week 1, 4, and 8

  At Baseline, Week 1, 4 and 8

• Change From Baseline in Sebumeter Values at Week 1, 4 and 8

  At Baseline, Week 1, 4 and 8

Study Arms (3)

No treatment and Standard cleanser

PLACEBO COMPARATOR

Participants randomised to the no treatment regimen will use the standard cleanser (only) twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours.

Other: Washout / Standard Cleanser

Test product and Standard cleanser

EXPERIMENTAL

Participants randomised to test product regimen will be instructed to use the standard cleanser and test product twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. Participants will be instructed to apply the test product cream immediately after cleansing.

Other: Washout / Standard Cleanser; Other: Test product

Positive control and positive cleanser

ACTIVE COMPARATOR

Participants randomised to positive control regimen will be instructed to use the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. Participants will be instructed to apply the positive control cream immediately after cleansing.

Other: Positive control cleanser; Other: Positive control moisturiser

Interventions

Washout / Standard Cleanser OTHER

Participants will apply standard cleanser (Simple Kind to Skin Moisturising Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the standard cleanser in a 5-7 day washout period and during the test phase of the study

No treatment and Standard cleanser; Test product and Standard cleanser

Test product OTHER

Participants will apply 0.6 gram (g) of Test product (Moisturising Cream with Niacinamide) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the test product during the test phase of the study.

Test product and Standard cleanser

Positive control cleanser OTHER

Participants will apply positive control cleanser (Neutrogena Visibly Clear Spot Clearing Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control cleanser during the test phase of the study.

Positive control and positive cleanser

Positive control moisturiser OTHER

Participants will apply 0.6 g of positive control moisturiser (Vivatinell Acnecinamide Gel Cream) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control moisturiser during the test phase of the study.

Positive control and positive cleanser

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Valinhos, 13271-130, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31461548 RESULT

Related Links

• Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomised proof-of-concept study.
• Related Info

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: March 28, 2017
• Study Start: April 4, 2017
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)