Last updated: 06/10/2019 10:10:34

Sun Protection Factor Determination (In vivo determination of the sun protection factor ISO 24444:2010(E))

GSK study ID
205795
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Sun Protection Factor Determination (In vivo determination of the sun protection factor ISO 24444:2010(E))
Trial description: This study aims to determine the Sun Protection Factor (SPF) of Test product in vivo on the back of human participants, according to the International Standard Sun Protection Test Method – In vivo determination of the sun protection factor (ISO 24444:2010(E)), by using a sun simulator.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Visual evaluation

Timeframe: 16-24 hours

Secondary outcomes:
Not applicable
Interventions:
  • Other: Negative Control
  • Other: Test product
  • Other: Positive Control
    • Enrollment:
    16
    Primary completion date:
    2016-29-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Skin Care
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    April 2016 to April 2016
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 Year
    Accepts healthy volunteers
    yes
    • Understanding of the study and willingness to participate as demonstrated by voluntary written informed consent
    • Age between 18 to 70 years (inclusive)
    • Breast feeding, pregnant women or who are intending to become pregnant over study duration
    • Acquired immunodeficiency syndrome (AIDS) or infectious hepatitis, insulin dependent diabetes, cancer, active skin disease at the test area, asthma or hypertension if not medicated, and medical history of dysplastic nevi or melanoma
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Understanding of the study and willingness to participate as demonstrated by voluntary written informed consent
    • Age between 18 to 70 years (inclusive)
    • Uniform skin and no erythema or dark pigmentation in the test area
    • Skin type I, II or III according to Fitzpatrick scale
    • Individual typological angle (ITA°) > 28 in the test area
    • Willingness to discontinue the use of detergents, cosmetic products in the treatment areas and to avoid any exposure of the test area to artificial or natural ultraviolet (UV) light throughout the study
    Exclusion criteria:
    • Breast feeding, pregnant women or who are intending to become pregnant over study duration
    • Acquired immunodeficiency syndrome (AIDS) or infectious hepatitis, insulin dependent diabetes, cancer, active skin disease at the test area, asthma or hypertension if not medicated, and medical history of dysplastic nevi or melanoma
    • Electronic implant that cannot be removed during irradiation
    • Sun exposition, UV therapy, artificial tanning within the last 4 weeks, or irregularly tanned skin in the test area
    • Application of leave-on cosmetics at the test area within the last 24 h prior to the study start
    • Moles, tattoos, scars, irritated skin, hair, etc. at the test area that could influence the investigation
    • Usage of medications with known photo-toxic and/or photo-sensitizing potential within the last 14 days prior to study start and/or throughout the entire study course
    • Medical history of abnormal response to sunlight
    • Systemic therapy with immuno-suppresive drugs and/or antihistamines within last 7 days prior to study start and/or throughout the entire study course
    • Systemic therapy with anti-phlogistic agents or analgetics within last 3 days prior to study start and/or throughout the entire study course
    • Participation or in waiting period of 2 months after participation in similar cosmetic and/or pharmaceutical UV studies
    • Known or suspected intolerance or hypersensitivity to cosmetic products
    • Alcohol or other substance of abuse within the last 5 years
    • Employee of the sponsor or the study site or members of their immediate family

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Schenefeld, Schleswig-Holstein, Germany, 22869
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2016-29-04
    Actual study completion date
    2016-29-04

    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
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