Last updated: 05/22/2019 05:50:13
Determination of the Sun Protection Factor (SPF) of a cosmetic daily de-fence skin cream
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 of a Cosmetic Daily Defence Skin Cream
Trial description: The purpose of this study is to determine the SPF of the test product according to the International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of the SPF).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Arithmetic mean of individual sun protection factor (SPFi) value
Timeframe: Up to 24 hours post UV exposure
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
26
Primary completion date:
2017-30-06
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)
May 2017 to June 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
- Subjects with a Fitzpatrick Skin Type of I, II or III
- Subjects with an Individual typological 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
- Subjects 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
- Subjects with a history of systemic therapy with anti-inflammatory agents or analgesics (e.g. diclofenac) up to 3 days prior to screening
- Subjects with dermatological conditions
- Subjects with a history of abnormal response to the sun
- Subjects who are tanned or have had sun exposure on the back area in the previous 4 weeks prior to screening
- Subjects having marks, blemishes or nevi or presenting existing sun damage in the test area
- Subjects having excessive hair, moles, tattoos, scars or other imperfections in the test area that could influence the investigation
- Subjects 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
- Subjects with a non-uniform skin colour or hyperpigmentation in the test area
- Subjects with a medical history of dysplastic nevi or melanoma
- Subjects with one of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
- Subjects with asthma, unless medicated
- Subjects with an electronic implant (e.g. pace maker, insulin pump, hearing aid) that cannot be removed during irradiation
- Acquired immune deficiency syndrome (AIDS) and infectious hepatitis, if known to the subjects
- 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
- Subjects who have used a tanning bed or other tanning treatment on the back area up to 1 month prior to screening
- Subjects accustomed to using tanning beds
- Subjects 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
- Subjects who will turn 71 years old before completing all assessment visits
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
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
2017-30-06
Actual study completion date
2017-30-06
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website