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)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2016-22-06
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
GSK Investigational Site
Schenefeld, Schleswig-Holstein, Germany, 22869
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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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