Last updated: 11/03/2018 22:50:18
Determination of SPF, before and after (40 and 80 minutes) of immersion in water, for a cosmetic product
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Determination of SPF, before and after (40 and 80 minutes) of immersion in water, for a cosmetic product
Trial description: The Present study will determine the Sun Protection Factor (SPF) and will evaluate the resistance to water (after 40 and 80 minutes immersion) of the test product
Primary purpose:
Not applicable
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Non-randomized
Primary outcomes:
SPF value between 35 and 50
Timeframe: Upto 24 hours
Water resistant (WR – 40 min)
Timeframe: Upto 24 hours
Very water resistant (VWR – 80 min)
Timeframe: Upto 24 hours
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
2
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 January 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18Years - 70Years
Accepts healthy volunteers
Yes
- Sign the informed consent form
- Healthy research participants
- Pregnant and breastfeeding women, or their partners
- Skin pathology in the area of product application (back)
Inclusion and exclusion criteria
Inclusion criteria:
- Sign the informed consent form
- Healthy research participants
- Intact skin on the test region (back)
- Agreement to comply with trial procedures and requirements, and to visit the institute on the day(s) and time(s) scheduled for the evaluations
- Ability to consent with participation in writing
- Gender: both
- Age group: 18-70 years old
- Phototype I to III, according to the Fitzpatrick scale
- ITAº higher than 28º
Exclusion criteria:
- Pregnant and breastfeeding women, or their partners
- Skin pathology in the area of product application (back)
- Type 1 Diabetes Mellitus, gestational or with complications (retinopathy, nephropathy, neuropathy) and/or insulin users and/or presence of dermatosis related to diabetes mellitus (plantar ulcer, necrobiosis lipoidica, granuloma annulare, dermatophytosis, deep mycosis, bacterial infections, opportunistic infections) 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
- Participants in use of antihistamine or anti-inflammatory medications, currently or during the week prior to the test and for a period greater than 3 days
- Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis or any other dermatosis which may interfere with the study results
- Other diseases or medications which may interfere directly with the study or jeopardize the volunteer’s health
- Personal or family history of skin cancer
- History of reaction to the category of the tested product
- History of allergies or sensitivity to cosmetics, toiletries, sunscreen and / or topical products
- Known allergy to latex
- History of allergy, phototoxic or photoallergic 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 (as defined in the Guide of Safety Evaluation of Cosmetics – ANVISA – 2012), the interval must be equal to or higher than 21 days
- Solar exposure on the test area (back) within less than 4 weeks
- Participation in tests for the measurement of SPF/UVAPF within less than 2 months (on the areas that will be used in this study)
- Participants in 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
- Participants who have used self-tanning products in their backs within less than 1 Month
- Participants who usually use tanning booths
- Relevant clinical history or current evidence of abuse of alcohol or other drugs
- Prisoners or participants involuntarily incarcerated
- Volunteers from indigenous tribes
- People working for Allergisa or the sponsoring company involved in the study or close relatives of an employee involved in the study
- Vaccination within 3 weeks before or during the study
- Participation in other studies (drugs, cosmetics or any other product) simultaneously to this test
- Presence of sunburn, tanning, uneven skin tone, spots, nevus, seborrheic keratosis or excessive hair on the area of the test.
- 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
Other
Actual primary completion date
Not applicable
Actual study completion date
2016-20-01
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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