Last updated: 06/10/2019 10:10:34
Sun Protection Factor Determination (In vivo determination of the sun protection factor 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 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
Observational study model:
Not applicable
Primary completion date:
2016-29-04
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
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
2016-29-04
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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