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NCT03119688

To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT)

Completed NA Results posted Last updated 2 May 2019
What this trial tests

NA trial testing Test Product in Skin Care in 50 participants. Completed in 26 May 2017.

Timeline
8 May 2017
Primary endpoint
26 May 2017
26 May 2017

Quick facts

Lead sponsorGlaxoSmithKline
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposebasic science
Enrollment50
Start date8 May 2017
Primary completion26 May 2017
Estimated completion26 May 2017
Sites2 locations across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Skin Care. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Visual Assessment of Dryness at Day 5 Primary · At Baseline and Day 5 (3 hours post last wash procedure)

Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not pr

GroupValue95% CI
Test0.48± 0.284
Positive Control0.91± 0.291
Negative Control0.56± 0.290
No Treatment0.63± 0.307
Change From Baseline in Visual Assessment of Redness at Day 5 Secondary · At Baseline and Day 5 (3 hours post last wash procedure)

Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.

GroupValue95% CI
Test0.01± 0.075
Positive Control0.00± 0.00
Negative Control0.00± 0.00
No Treatment0.00± 0.00
Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4 Secondary · At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)

Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not pr

Day 2
GroupValue95% CI
Test0.25± 0.253
Positive Control0.46± 0.307
Negative Control0.28± 0.251
Reference (Unwashed Area)0.31± 0.265
Day 3
GroupValue95% CI
Test0.37± 0.248
Positive Control0.66± 0.298
Negative Control0.38± 0.285
Reference (Unwashed Area)0.42± 0.260
Day 4
GroupValue95% CI
Test0.43± 0.255
Positive Control0.76± 0.314
Negative Control0.42± 0.240
Reference (Unwashed Area)0.55± 0.302
Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4 Secondary · At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)

Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.

Day 2
GroupValue95% CI
Test0.06± 0.167
Positive Control0.05± 0.154
Negative Control0.01± 0.072
Reference (Unwashed Area)0.01± 0.072
Day 3
GroupValue95% CI
Test0.00± 0.00
Positive Control0.00± 0.00
Negative Control0.00± 0.00
Reference (Unwashed Area)0.00± 0.00
Day 4
GroupValue95% CI
Test0.00± 0.00
Positive Control0.01± 0.075
Negative Control0.00± 0.00
Reference (Unwashed Area)0.02± 0.151
Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5 Secondary · At Baseline and Day 5 (3 hours post last wash procedure)

TEWL was measured using Tewameter. TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 seconds (sec), to ensure that a stable value has been established. The first part of the measurement belonged to the equilibration phase. The values of the last 10 sec were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.

GroupValue95% CI
Test Product0.91± 2.118
Positive Control1.95± 2.025
Negative Control0.94± 1.714
No Treatment0.53± 1.682
Change From Baseline in Skin Moisturisation at Day 5 Secondary · At Baseline and Day 5 (3 hours post last wash procedure)

Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the gold conductors of the probe an electrical field was built which allowed the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content, the stratum corneum moisturisation can be measured. The Corneometer probe was placed in contact with the skin of the paarticipant's test site for 1-2 seconds per measurement

GroupValue95% CI
Test2.35± 5.341
Positive Control-4.57± 5.368
Negative Control2.13± 4.803
No Treatment0.34± 3.729

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately 5 days. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test
Serious: 0/48 (0%)
Deaths: 0/48
Positive Control
Serious: 0/48 (0%)
Deaths: 0/48
Negative Control
Serious: 0/48 (0%)
Deaths: 0/48
No Treatment
Serious: 0/48 (0%)
Deaths: 0/48
Overall Participants
Serious: 0/48 (0%)
Deaths: 0/48
Other adverse events (6 terms — click to expand)

ReactionSystemTestPositive ControlNegative ControlNo TreatmentOverall Participants
APPLICATION SITE PAINGeneral disorders
FOOD POISONINGGastrointestinal disorders
TOOTHACHEGastrointestinal disorders
APPLICATION SITE PRURITUSGeneral disorders
THERMAL BURNInjury, poisoning and procedural complications
ARTHROPOD BITEInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT03119688 adverse events section.

Sponsor's own description

The objective of this clinical study is to assess the relative mildness of a cosmetic facial cleanser in comparison to water through repeated application to the volar forearm using the FCAT wash procedure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Clinical Measurement of Transepidermal Water Loss.
    Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148

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Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03119688.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing