Last updated: 03/10/2020 14:50:07

Exploratory Study to Assess the Utility of an Optical Imaging System to Detect Early Cellular Level Changes Upon Exposure to UV Light

GSK study ID
202185
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Exploratory Study to Assess the Utility of an Optical Imaging System to Detect Early Cellular Level Changes Upon Exposure to UV Light
Trial description: The purpose of this study is to evaluate the capability of non-invasive optical biopsy techniques to detect molecular and morphological differences in healthy human subjects in vivo before and after exposure to UV light with and without sunscreen.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Non-randomized
Primary outcomes:

Detect optical oxidation-reduction (Redox) ratios between non-UV exposed, UV-exposed and UV-exposed sunscreen ratios treated skin

Timeframe: Baseline to Day 3

Secondary outcomes:

Detect morphological changes between non UV-exposed, UV-exposed and UV-exposed sunscreen treated skin

Timeframe: Baseline to Day 3

Interventions:
Procedure: Exposure to simulated sunlight
Enrollment:
0
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Sunscreening Agents
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2015 to October 2015
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 64 Year
Accepts healthy volunteers
yes
  • Only otherwise healthy fair-skin adults (21-50 years of age) who have
  • Fitzpatrick skin type II
  • Existence of chronic, inflamatory or systemic illness influencing barrier function of the skin
  • History of intolerability or sensitivities to any of the active or the passive ingredients
Inclusion and exclusion criteria
Inclusion criteria:
  • Only otherwise healthy fair-skin adults (21-50 years of age) who have Fitzpatrick skin type II -No history of medications that produce abnormal sunlight responses -No history of having any abnormal responses to sunlight such as phototoxic or photoallergic responses -Able to understand and provide written informed consent
Exclusion criteria:
  • Existence of chronic, inflamatory or systemic illness influencing barrier function of the skin -History of intolerability or sensitivities to any of the active or the passive ingredients -Volunteers who had a history or showed signs of intolerability and/or oversensitivity towards any further active and/or passive ingredients of the test preparation

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website