Status:
COMPLETED
Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.
Lead Sponsor:
Herbarium Laboratorio Botanico Ltda
Conditions:
Sensitivity, Contact
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a clinical study for health care product safety assessment. The research is going to conducted with 55 subjects, aged 18 to 70 years. The product is applied on the right and/or left participan...
Detailed Description
Subjects phototypes I to IV (according to Fitzpatrick classification). The products is applied over semi-occlusive dressings, remaing in contact with the skin.
Eligibility Criteria
Inclusion
- Healthy participants;
- Non-injured skin in the test region;
- Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations;
- Ability to consent to participation in the study;
- Phototype (Fitzpatrick): II and III;
Exclusion
- Pregnant or breastfeeding women;
- Use of the following systemic drugs: antihistamines, non-hormonal anti-inflammatory drugs and corticoids;
- History of allergy to cosmetics, topical products or research product;
- Localized or widespread dermatological diseases or inflammatory dermatoses active and nerve damage in the test region;
- Personal or family pathological history of skin cancer;
- Use of topical or systemic photosensitizing medication;
- History of phototoxic, photoallergic reactions, dermatoses caused by light, atopy, pathologies aggravated or triggered by ultraviolet radiation;
- Photo-induced pathologies;
- Frequent exposure to the sun or tanning chambers;
- Participated in an allergenicity study in a period of less than 4 weeks from the start of the study;
- Skin marks in the experimental area that interfere with the evaluation of possible reactions;
- Active dermatoses;
- Forecast to take a bath in the sea, pool or sauna during the study;
- Participants who play water sports;
- Dermography;
- Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids up to 2 weeks prior to selection or, considering deposit corticoids, the interval shall be 1 month prior to selection;
- Treatment with acid vitamin A and/or its derivatives via oral or topical until
- 1 month before the beginning of the study;
- Aesthetic and/or body dermatological treatment until 3 weeks before selection;
- Vaccination during the study or until 3 weeks before the study;
- Being participated in another clinical trial.
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2020
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04332445
Start Date
October 26 2020
End Date
December 3 2020
Last Update
November 10 2021
Active Locations (1)
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1
Kosmoscience Ciência e Tecnologia Cosmética Ltda
Campinas, São Paulo, Brazil, 13041-315