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 5Primary· 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
Group
Value
95% CI
Test
0.48
± 0.284
Positive Control
0.91
± 0.291
Negative Control
0.56
± 0.290
No Treatment
0.63
± 0.307
Change From Baseline in Visual Assessment of Redness at Day 5Secondary· 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.
Group
Value
95% CI
Test
0.01
± 0.075
Positive Control
0.00
± 0.00
Negative Control
0.00
± 0.00
No Treatment
0.00
± 0.00
Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4Secondary· 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
Group
Value
95% CI
Test
0.25
± 0.253
Positive Control
0.46
± 0.307
Negative Control
0.28
± 0.251
Reference (Unwashed Area)
0.31
± 0.265
Day 3
Group
Value
95% CI
Test
0.37
± 0.248
Positive Control
0.66
± 0.298
Negative Control
0.38
± 0.285
Reference (Unwashed Area)
0.42
± 0.260
Day 4
Group
Value
95% CI
Test
0.43
± 0.255
Positive Control
0.76
± 0.314
Negative Control
0.42
± 0.240
Reference (Unwashed Area)
0.55
± 0.302
Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4Secondary· 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
Group
Value
95% CI
Test
0.06
± 0.167
Positive Control
0.05
± 0.154
Negative Control
0.01
± 0.072
Reference (Unwashed Area)
0.01
± 0.072
Day 3
Group
Value
95% CI
Test
0.00
± 0.00
Positive Control
0.00
± 0.00
Negative Control
0.00
± 0.00
Reference (Unwashed Area)
0.00
± 0.00
Day 4
Group
Value
95% CI
Test
0.00
± 0.00
Positive Control
0.01
± 0.075
Negative Control
0.00
± 0.00
Reference (Unwashed Area)
0.02
± 0.151
Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5Secondary· 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.
Group
Value
95% CI
Test Product
0.91
± 2.118
Positive Control
1.95
± 2.025
Negative Control
0.94
± 1.714
No Treatment
0.53
± 1.682
Change From Baseline in Skin Moisturisation at Day 5Secondary· 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
Group
Value
95% CI
Test
2.35
± 5.341
Positive Control
-4.57
± 5.368
Negative Control
2.13
± 4.803
No Treatment
0.34
± 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.
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):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 2 May 2019
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.