Last updated: 10/24/2019 05:40:15
A study to measure the sun protection factor and UVA protection factor of four developmental sunscreen formulations
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Determination of the Sun Protection Factor (SPF) and in vitro Ultraviolet-A Protection Factor (UVAPF) of four developmental sunscreen formulations
Trial description: The purpose of this study is to determine the SPF and UVAPF of four sunscreen formulations using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Arithmetic mean of Individual sun protection factor (SPFi) values
Timeframe: Up to 24 hours post UV exposure
Secondary outcomes:
Arithmetic mean Individual ultraviolet-A protection factor (UVAPFi)
Timeframe: Up to 30 minutes post UV exposure
Critical wavelength
Timeframe: Up to 30 minutes post UV exposure
Spectrum of sun protection
Timeframe: Up to 30 minutes post UV exposure
Interventions:
Enrollment:
8
Primary completion date:
2017-07-07
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 2017 to July 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding or lactating
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
- Participants with a Fitzpatrick Skin Type of I, II or III
- Participants with an Individual Typology Angle (ITA°) greater than 28°
Exclusion criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding or lactating
- Participants having used medication with known photo-toxic and/or photosensitizing potential (e.g. hypericum perforatum, antibiotics, blood pressure regulating agents) up to 14 days prior to screening
- Participants with a history of systemic therapy with anti-inflammatory agents or analgesics (e.g. diclofenac) up to 3 days prior to screening
- Participants with dermatological conditions
- Participants with a history of abnormal response to the sun
- Participants having marks, blemishes or nevi or presenting existing sun damage in the test area
- Participants having excessive hair, moles, tattoos, scars or other imperfections in the test area that could influence the investigation
- Participants with a history of systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. anti-allergics) up to 7 days prior to screening
- Participants with a non-uniform skin colour or hyperpigmentation in the test area
- Participants with a medical history of dysplastic nevi or melanoma
- Participants with one of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
- Participants with asthma, unless medicated
- Participants with an electronic implant (e.g. pace maker, insulin pump, hearing aid) that cannot be removed during irradiation
- AIDS (acquired immune deficiency syndrome) and infectious hepatitis, if known to the participants
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Known allergy to latex
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days prior to screening
- Participation in another clinical study involving UV exposure to the same test site up to 2 months prior to screening
- Previous participation in this study
- Recent history (within the last 5 years) of alcohol or other substance abuse
- Participants who have used a tanning bed or other tanning treatment on the back area up to 1 month prior to screening
- Participants accustomed to using tanning beds
- Participants who have used self-tanning products on the back area in the previous 1 month prior to screening
- An 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
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Protocol and statistical analysis plan
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
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2017-07-07
Actual study completion date
2017-07-07
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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