Last updated: 11/03/2018 22:51:09
Clinical, Single-blind and Controlled Study of the Potential of Cutaneous Photosensitization and Phototoxicity of a cosmetic product SB
GSK study ID
204805
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: Clinical, Single-blind and Controlled Study of the Potential of Cutaneous Photosensitization and Phototoxicity of a cosmetic product SB
Trial description: The contact of the skin with topical products, such as cosmetic products, may trigger different types of reactions like eczematous contact dermatitis, urticaria, acne and spots. Once the cosmetic product becomes freely available for the consumer, it must be safe when applied under normal or reasonably foreseeable conditions of use. The objective of the study will be to prove confirm the absence of adverse events during the first application of the cosmetic product to the skin, therefore confirming that the product is safe for use. The conduction of safety clinical studies, before products commercialization and coordinated by specialized doctors, provide more safety, credibility and confidence to the industry in relation to their consumers. Compatibility studies, performed with patch tests, aim to confirm the absence of adverse events during the first application of a cosmetic product to the skin, therefore confirming that the product is safe for use. They consist of repeated applications of the product to the skin, assessing the non-occurrence of irritation or sensitization. The absence of photosensitization or photoirritant potential can also be assessed. The study will observe the effects of product’s application on the skin and prove the non-appearance of photoallergy and/or phototoxicity.
Primary purpose:
Not applicable
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Non-randomized
Primary outcomes:
Photoallergy and phototoxicity assessment by Patch Test
Timeframe: Week 1 to Week 6
Assessment of clinical signs
Timeframe: Week 1 to Week 6
Secondary outcomes:
Not applicable
Interventions:
Other: Test product
Radiation: UV radiations
Other: Reference product
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2017-23-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2017 to February 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18Years - 70Years
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.
- Ability of giving a written consent for his/her participation
- Pregnant, Breastfeeding or spouses of pregnant or breast feeding women
- Any skin marks on the test site that might interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased pilosity, and great amounts of ephelides and nevus, sunburns)
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. -Ability of giving a written consent for his/her participation -Sign the informed consent -Aged between 18 and 70 years old inclusive -Both gender (male or female) -Healthy study participants -Intact skin on test site -Agreement to comply with the procedures and requirements of the study and to attend to the contract research organization (CRO) on the scheduled assessment -Phototype (Fitzpatrick): II and III
Exclusion criteria:
- Pregnant, Breastfeeding or spouses of pregnant or breast feeding women -Any skin marks on the test site that might interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased pilosity, and great amounts of ephelides and nevus, sunburns) -Active dermatosis (local or disseminated) that might interfere with the results of the study -History of diseases aggravated or triggered by ultraviolet radiation -Participants suffering from immunodeficiencies -Participants with dermatographism -Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 02 weeks before the selection of participants -Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the beginning of the study -Intention of being vaccinated during the study period or vaccination within 3 weeks of beginning the study -Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication -Study participants with allergy history to the study material -Being part of a clinical study or have participated of a clinical study completed less than 07 days before the selection and 21 days if the previous study is a compatibility or Adverse Reaction investigation study -Previous participation in a study with the same product under test -Professionals who are directly involved in the performance of the current protocol as well as their relatives -Intense sunlight exposure or sun tanning sessions up to 15 days before the baseline evaluation or during the study -Intention of intense sunlight exposure or sun tanning sessions during the study period -Intention of sea bathing, going to the pool or bathtub, sauna or water sports or the ones which leads to intense sweating during the study -Prisoners or involuntary incarcerated participants -Participants from indigenous tribes -Relevant medical history or current evidence of alcohol or illicit drugs -Aesthetic and/or dermatological treatment performed on the body within 3weeks before selection or during the study -History of lack of adherence or unwillingness to adhere to the study protocol -Participants who do not show good overall and mental health and that, in the opinion of the investigator or designated doctor , show any clinically significant abnormalities , relevant and / or could affect the safety and quality of life of the participants -Any conditions which the investigator finds compromising to the evaluation of the study
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website