Last updated: 11/03/2018 23:19:51
Determination of SPF, before and after immersion in water, for a cosmetic product at minimum of 3 subjects.
GSK study ID
205431
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: Determination of SPF, before and after immersion in water, for a cosmetic product at minimum of 3 subjects.
Trial description: The Present study will determine the preliminary Sun Protection Factor (SPF) and resistance to water of the test product in at least 3 study participants.The study consists of the application of an investigational product (IP) on study participants back in order obtain a minimum of 3 participants with valid results for each group, tested with 40 and 80 minutes of immersion. This is a screening study for preliminary evaluation of SPF in vivo. The study will be performed with two groups. The first one will perform the research under dry conditions and with a 40-minute immersion in water, and a second one will perform the research under dry conditions and with an 80-minute water immersion. Once the product has presented resistance to water at 40 min, the sponsor will decide if the test at 80 min of immersion will be conducted, which is the second part of the protocol The study of SPF measurement follows the ISO 24444: 2010 Cosmetics -- Sun protection test methods - In vivo determination of the sun protection factor (SPF) and the COLIPA Guidelines for Evaluating Sun Protect Water Resistance
Primary purpose:
Screening
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
SPF 80
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:
Other: Reference product
Other: Study product
Other: UVA radiation
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2016-08-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2016 to September 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 70 Year
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 participants in the investigator’s opinion.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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