CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 157 enrolled
Drug / intervention
Washout / Standard Cleanser +3 moreother
Likely dose
0.6 gram of Moisturising Cream with Niacinamide applied topically twice daily (morning and night)AI-extracted
Key inclusion· 5
  • Minimum 10 and maximum 25 blemishes (papules and pustules) at baseline visit, and minimum 8 at follow-up visit 2
  • Sebumeter score >66 µg/cm² at the forehead
  • Fitzpatrick skin types I–V
  • Good general and mental health with no clinically significant abnormalities in medical history or physical examination
Key exclusion· 9
  • Medicated acne treatment (e.g., benzoyl peroxide, clindamycin, isotretinoin) within the last 12 months
  • Medically diagnosed acne vulgaris, acne conglobate, fulminans, secondary acne, or any acne requiring systemic or topical treatment
  • Systemic immunosuppressive drugs (e.g., corticosteroids) and/or antihistamines within 7 days prior to start and throughout study
  • Systemic anti-microbials within the last month

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03093181
NCT03093181N/ACompleted

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

GlaxoSmithKline·interventional·Posted Mar 28, 2017·Updated Feb 24, 2020

In Brief

A clinical study evaluating Washout / Standard Cleanser, Test product, and 2 other interventions for Skin Care. Completed, enrolled 157 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Care
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 28, 2017
Enrollment StartApr 4, 2017
Primary CompletionAug 28, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.3 years ago

Interventions

Washout / Standard Cleanserother

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

Test productother

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.

Positive control cleanserother

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 moisturiserother

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.