Last updated: 06/06/2019 05:00:37

Sun Protection Factor Determination: In vivo Determination of the Sun Protection Factor (SPF): ISO 24444:2010(E)

GSK study ID
205865
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 (SPF): ISO 24444:2010(E)
Trial description: This randomized, blinded, intra-individual comparison, controlled application study will determine the Sun Protection Factor (SPF) of 8 sunscreen formulations in vivo on the backs of human participants, according to the International Standard Sun Protection Test Method – In vivo determination of the sun protection (ISO 24444:2010(E)), factor by using a solar simulator.
Primary purpose:
Not applicable
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Visual Evaluation

Timeframe: 16-24 hours

Secondary outcomes:
Not applicable
Interventions:
  • Other: Test product H
  • Other: Test product F
  • Other: Negative control
  • Other: Test product D
  • Other: Test product G
  • Other: Test product B
  • Other: Test product E
  • Other: Positive control
  • Other: Test product C
  • Other: Test product A
    • Enrollment:
    38
    Primary completion date:
    2016-22-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sunscreening Agents
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    June 2016 to June 2016
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 Year
    Accepts healthy volunteers
    yes
    • Written Informed Consent to participate in the study. Demonstrates understanding of the study and
    • Willingness to participate as evidenced by voluntary written informed consent
    • Women who are breast–feeding
    • Women who are known to be pregnant or are intending to become pregnant over the duration of the
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Written Informed Consent to participate in the study. Demonstrates understanding of the study and
    • Willingness to participate as evidenced by voluntary written informed consent
    • Willingness to actively participate in the study, to come to the scheduled visits and to comply with all study procedures and restrictions
    • Between 18 to 70 years of age (inclusive)
    • Uniform skin color and no erythema or dark pigmentation in the test area
    • Skin type I, II or III according to the Fitzpatrick Scale
    • Individual Typological Angle (ITA°) > 28 in the test area
    Exclusion criteria:
    • Women who are breast–feeding
    • Women who are known to be pregnant or are intending to become pregnant over the duration of the study
    • AIDS or infectious hepatitis if known to the participants
    • Participation or being in the waiting period of 2 months after participation in similar cosmetic and/or pharmaceutical ultra-violet (UV) studies
    • One of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
    • One of the following illnesses if not medicated: Asthma, hypertension
    • Electronic implant (e.g. pace maker, insulin pump, hearing aid, and the like) that cannot be removed during irradiation
    • Documented allergies to cosmetic products or study product ingredients
    • Active skin disease at the test area
    • Medical history of dysplastic nevi or melanoma
    • Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the investigation
    • Usage of medication with known photo-toxic and/or photo-sensitizing potential (e.g. hypericum perforatum, antibiotics, blood pressure regulating agents) within the last 14 days prior to the start of the study and/or throughout the entire course of the study
    • Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and/or throughout the entire course of the study.

    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
    2016-22-06
    Actual study completion date
    2016-22-06

    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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    Access to clinical trial data by researchers
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