Last updated: 11/03/2018 22:50:24
Determination of UVA Protection Factor (UVAPF) for a cosmetic product
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Determination of UVA Protection Factor (UVAPF) for a cosmetic product
Trial description: Ultraviolet A (UVA) rays penetrate the skin up to the reticular dermins, causing photobiological changes in an indirect manner. The regular use of sunscreens has proved to be efficient in reducing skin effects from UV irradiation, especially erythema, dermal changes and carcinogenesis. This will be an open-label, parallel-control, clinical study to determine the UVA Protection Factor (UVA-PF) of the test product according to the International Organization for Standardization (ISO) 24442, cosmetics- sun protection test method.
Primary purpose:
Not applicable
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
UVA-PF value determination
Timeframe: Up to 24 hours
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
10
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2015 to February 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 70 Year
Accepts healthy volunteers
yes
- Signed consent form; ability to consent with participation in writing
- Intact skin on the test region (back)
- Pregnant and breastfeeding women, or their partners
- Skin pathology in the area of product application (back); skin diseases which may interfere with the study results
Inclusion and exclusion criteria
Inclusion criteria:
- Signed consent form; ability to consent with participation in writing
- Intact skin on the test region (back)
- Agreement to comply with trial procedures and requirements, and to visit institute on the day(s) and time(s) scheduled for the evaluations
- Both gender; 18-70 years age; healthy participants
- Phototype II to IV skin type according to Fitzpatrick scale
- Individual typology angle (ITAº) from 20º to 41º
Exclusion criteria:
- Pregnant and breastfeeding women, or their partners
- Skin pathology in the area of product application (back); skin diseases which may interfere with the study results
- Type I Diabetes Mellitus and/or history of hypoglycemic episodes, diabetic ketoacidosis and/or hyperosmolar coma; immune failure; use of systemic corticosteroids or immunosuppressants within 2 weeks prior to study start
- Personal/family history of cancer; use of antihistamines or anti-inflammatory medications (currently/during the week prior to the test and for a period more than 3 days)
- Other disease or medications which may interfere directly with the study or jeopardize the participants health
- History of reactions, allergies or sensitivity to the category of the tested product; cosmetics, toiletries, sunscreen and/or topical products; known allergy to latex; phototoxic or photo-allergic reactions or abnormal response to solar exposure
- Participation in other studies within the last 7 days; in case the previous test is any compatibility test, the interval must be equal to or higher than 21 days
- Solar exposure on the test area within less than 4 weeks
- Participation in the tests for the measurement of sun protection factor (SPF)/UVAPF within less than 2 months
- Use of tanning booths; use of self tanning products on their back within less than 1 month
- Use of photosensitizing potential drugs, medications and/or dietary supplements capable of inducing skin color, or corticosteroids, currently or during the month prior to test
- Relevant clinical history or current evidence of abuse of alcohol or other drugs
- Vaccination during study or within 3 weeks prior to the study start
- Prisoners or participants voluntarily incarcerated; indigenous tribes; participants working for Allergisa or the sponsor company or close relative of an employee involved in the study
- Participation in other studies simultaneously to this UVA panel
- Presence of sunburn, tanning, uneven skin tone, spots, nevus, seborrheic keratosis or excessive hair on the test area
- Any condition not previously mentioned that may impair the study evaluation and/or safety of the participant in the investigator's opinion
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2016-02-02
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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