Rhinitis
Conditions
Interventions
Clinical, comparative, single-blind, controlled study. The experimental product is a Nasal Spray (0.04% sodium hyaluronate and 1% dexpanthenol solution). For this research, up to 150 participants aged
Sponsors
Allergisa Pesquisa Dermato-Cosmetica Ltda
Allergisa Pesquisa Dermato-Cosmetica Ltda
Megalabs Farmacêutica S.A.
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Agreement to comply with safety guidelines to minimize the risks of contamination with COVID-19; healthy participants; both genders; intact skin in the test region; agreement to adhere to trial procedures, scheduled visits, and requirements; ability to consent to your participation in the study in writing; age 18 to 70 years; phototype (Fitzpatrick) I to IV
Exclusion criteria
Exclusion criteria: Participants who belong to the risk group for COVID-19 (diabetes, with chronic cardiovascular, kidney and respiratory problems, immunosuppressed or other conditions that the doctor judges as belonging to the risk group); pregnant or lactating women; skin marks in the experimental area that interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, freckles and nevus in large numbers, sunburn); active dermatoses (local or disseminated) that may interfere with the study results; history of allergic reactions, irritation or intense feelings of discomfort to topical cosmetics, health products or medications; history of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.); discomfort with changes in temperature (too hot/too cold) and/or when using air conditioning; participants with a history of allergy to the materials used in the study; participants with known allergy to acrylates; history of pathologies aggravated or triggered by ultraviolet radiation; people with immunodeficiencies; intense sun exposure or tanning session up to 15 days before the initial assessment; prediction of intense sun exposure or tanning session during the study period; planning to take a bath in the sea, pool or bathtub during the study; participants who practice water sports; dermographism; body aesthetic and/or dermatological treatment up to 03 weeks before selection; use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs and corticosteroids up to 2 weeks before selection or, considering deposit corticosteroids, the interval should be 1 month before selection; treatment with acidic vitamin A and/or its derivatives orally or topically up to 01 month before the beginning of the study; prediction of vaccination during the study or up to 03 weeks before the study; be participating or have participated in another clinical study that ended less than 07 days before the selection, in case the previous study was acceptable in use; be participating or have participated in another clinical study that ended less than 21 days ago, if the previous study is a compatibility or investigative study of Adverse Reaction; any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study; history of non-adherence or unwillingness to adhere to the study protocol; professionals directly involved in carrying out this protocol and their family members
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of irritability potential and skin sensitization of the experimental product, evaluated by patch test, also known as patch or epicutaneous test, under maximized conditions, with controlled area of application and quantity. Reaction assessments will be performed using the International Contact Dermatitis Investigator Group Scale – ICDRG, 3 times a week for 3 consecutive weeks during the induction period, followed by a reaction assessment (challenge) after 10 days of rest. The results will be presented in the form of tables demonstrating whether or not there was a positive response to irritability or skin sensitization in the study group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactMariane Martins
Allergisa Pesquisa Dermato-Cosmetica Ltda
Outcome results
None listed