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A Study to Evaluate of Cosmetic Benefit of a Moisturising Cream in People With Blemish Prone Skin | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT03093181•GlaxoSmithKline

View on ClinicalTrials.gov

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

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

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
+13 more criteria

Locations (1)

GSK Investigational Site

Valinhos, Brazil

Key Dates

Start Date

April 4, 2017

Primary Completion Date

August 28, 2017

Completion Date

August 28, 2017

Last Updated

February 24, 2020

Enrollment

157

ACTUAL participants

Conditions

Skin Care

Interventions

Washout / Standard Cleanser

OTHER

Test product

OTHER

Positive control cleanser

OTHER

Positive control moisturiser

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Evaluation of the EF192B Protection Versus No Treatment

The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates

A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations.

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