Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
DermatitisContactOpen, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.
Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study...
Contact DermatitisThe purpose of this study is to evaluate the diagnostic performance and safety of ascending doses of mercury, aluminum and palladium metal allergens proposed for inclusion in a metal allergen panel. Optimal dose will be selected based on the lowest dose of each allergen eliciting a positive response in 70-90% of subjects tested.
Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
Allergic Contact DermatitisThe objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization
SensitivityContactThis is a clinical study for health care product safety assessment. The research will be conducted with 92 subjects, aged 18 to 59 years. The product will be applied on the right and/or left back of the research participants for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 48 hours. Medical evaluation will be available throughout the study to assess possible adverse events. The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy.
Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
Contact DermatitisWe propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").
The Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention...
Contact Dermatitis of HandsOccupational hand dermatitis (OHD) often occurs in intensive care unit (ICU) nurses, especially in individuals who are vulnerable due to irritant exposure e.g. hand rub alcohol and repeated hand washing activities. The use of moisturizer is one of the recommendations for skin care in OHD. Niacinamide which has anti-inflammatory effects and can improve the skin barrier function. Virgin coconut oil (VCO) is rich in lipids and lauric acid, and has an occlusive effect. Until now there are no guidelines and reference types of moisturizers for secondary prevention in DTAK.
Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy
Contact DermatitisWe propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.
Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate...
Allergic Contact DermatitisIt is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing allergic contact dermatitis.
Evaluation of Cutaneous Acceptability and Perceived Effectiveness of a Nasal Spray (Health Care...
AcceptanceSocial2 moreThis is a clinical study for health care product safety assessment. The research is going to conducted with 45 subjects, aged 18 to 70 years, women users of the product category, regardless of color/race, ethnicity, sexual orientation, classes and social groups and who must present all the other characteristics of the inclusion criteria and no exclusion characteristics. The product is applied under real conditions of use, in a panel of survey participants corresponding to the target consumers. Medical evaluation will be available throughout the study to assess possible adverse events. The main of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy and perceived acceptability.
Prospective Single Center Randomized Double Blind Controlled Tolerability Trial of Six Hair Cleansing...
Irritant Contact DermatitisHair cleansing product tolerability study