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NCT03136107

Determination of the Sun Protection Factor (SPF) of a Cosmetic Daily De-fence Skin Cream

Completed NA Results posted Last updated 19 April 2019
What this trial tests

NA trial testing Physiogel Daily Defence Protective Day Cream Light in Sunscreening Agents in 26 participants. Completed in 30 June 2017.

Timeline
30 May 2017
Primary endpoint
30 June 2017
30 June 2017

Quick facts

Lead sponsorGlaxoSmithKline
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment26
Start date30 May 2017
Primary completion30 June 2017
Estimated completion30 June 2017
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 70, any sex, with Sunscreening Agents. 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.

Arithmetic Mean of Individual Sun Protection Factor (SPFi) Value Primary · Up to 24 hours post UV exposure

Arithmetical mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to ultraviolet (UV) radiation (SPFi = MEDp/MEDu). The Minimal Erythemal Dose (MED) was defined as the lowest dose of UV radiation that produced the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure, 16 to 24 hours after UV exposure. No inferential statistical analysis has been performed fo

GroupValue95% CI
Test Product19.416.24 – 22.63
Reference Product14.011.70 – 16.36

Sponsor's own description

The purpose of this study is to determine the SPF of the test product according to the International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of the SPF).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Trials by the same sponsor.

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Data sources for this page

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/NCT03136107.

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