Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization of Hyaluronic Nasal Spray
Primary Purpose
Sensitivity, Contact
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hyaluronic Nasal Spray
Sponsored by
About this trial
This is an interventional other trial for Sensitivity, Contact
Eligibility Criteria
Inclusion Criteria:
- Healthy research participant
- Age range between 18 and 70 years.
- Gender: female and male.
- Phototype (Fitzpatrick): I to IV.
- Agree to adhere to the requirements of the study in the fight against the COVID-19 pandemic, through preventive measures: use a mask according to WHO guidelines; use the mask while traveling to the research center and during the study procedures; maintain social distancing; wash hands frequently with soap and/or alcohol gel and go to the research center only at scheduled times to avoid agglomerations.
- Agree not to wet the site during the entire test period;
- Understand the test procedures and agree to their adherence to the study requirements;
- Absence of inflammatory dermatoses or tattoo at the application site;
- Signing of the Free and Informed Consent Term (FICT).
Exclusion Criteria:
- Pregnancy, lactation;
- Participants with hyperthermia (body temperature greater than or equal to 37.5ºC);
- Participants who have been diagnosed with COVID-19 by RT-PCR exam or by the presence of IgM antibodies in the serology exam, in the last 4 weeks or who are presenting the following symptoms: dry or productive cough, sneezing, runny nose, body pain , headache, anosmia (loss of smell), ageusia (loss of taste) and/or any other symptom that may be related to covid-19 at the discretion of the investigator;
- Participant who belongs to the risk group for COVID-19, that is, with cardiovascular, renal and chronic respiratory problems, immunosuppressed or other conditions that the doctor judges as belonging to the risk group;
- Participants with heart disease (eg, but not limited to: atrial fibrillation, obstructive coronary artery disease);
- Participants with renal and/or neurological diseases;
- Participants with severe or decompensated lung and/or respiratory diseases;
- Use of corticosteroids, antihistamines and/or anti-inflammatory drugs;
- Presence of localized or generalized skin diseases;
- Presence of active inflammatory dermatoses in the test region;
- Frequent exposure to the sun or tanning beds;
- Have participated in an allergenicity study within a period of less than four weeks from the beginning of the study;
- Research participants with a history of allergy to the material used in the study;
- Atopy history;
- History of pathologies aggravated or triggered by ultraviolet radiation;
- Immunodeficiency carriers;
- Forecast of intense sun exposure or tanning session during the study period;
- Forecast to take a bath in the sea, swimming pool or sauna during the study;
- Research participants who practice water sports;
- Research participants with dermographism;
- Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticosteroids up to 2 weeks before selection;
- Treatment with acidic vitamin A and/or its derivatives orally or topically up to 1 month before the start of the study;
- Aesthetic and/or dermatological body treatment up to 03 weeks before selection;
- Vaccination forecast during the study or up to 03 weeks before the study;
- Any condition not mentioned above that, in the opinion of the investigator, could 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 families.
- Be participating in some other study at the moment.
- Any condition that, in the opinion of the researcher, could compromise the study.
Sites / Locations
- Kosmoscience Ciência e Tecnologia Cosmética Ltda
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Outcomes
Primary Outcome Measures
Absence
Absence occurence of phototoxicity and photoallergy
Secondary Outcome Measures
Full Information
NCT ID
NCT05508243
First Posted
August 18, 2022
Last Updated
March 15, 2023
Sponsor
Herbarium Laboratorio Botanico Ltda
1. Study Identification
Unique Protocol Identification Number
NCT05508243
Brief Title
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization of Hyaluronic Nasal Spray
Official Title
Dermatologist-supervised Assessment of Primary and Accumulated Irritation Potential and Skin Sensitization Potential for the NASAL SPRAY Product
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
November 24, 2022 (Actual)
Study Completion Date
November 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Herbarium Laboratorio Botanico Ltda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability and Dermal Sensitization, of health products through the application of Patch Test, proving the safety of the product for topical use. The study will be conducted with a Brazilian sample in which 65 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity, Contact
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Hyaluronic Nasal Spray
Intervention Description
Health care product - nasal application
Primary Outcome Measure Information:
Title
Absence
Description
Absence occurence of phototoxicity and photoallergy
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy research participant
Age range between 18 and 70 years.
Gender: female and male.
Phototype (Fitzpatrick): I to IV.
Agree to adhere to the requirements of the study in the fight against the COVID-19 pandemic, through preventive measures: use a mask according to WHO guidelines; use the mask while traveling to the research center and during the study procedures; maintain social distancing; wash hands frequently with soap and/or alcohol gel and go to the research center only at scheduled times to avoid agglomerations.
Agree not to wet the site during the entire test period;
Understand the test procedures and agree to their adherence to the study requirements;
Absence of inflammatory dermatoses or tattoo at the application site;
Signing of the Free and Informed Consent Term (FICT).
Exclusion Criteria:
Pregnancy, lactation;
Participants with hyperthermia (body temperature greater than or equal to 37.5ºC);
Participants who have been diagnosed with COVID-19 by RT-PCR exam or by the presence of IgM antibodies in the serology exam, in the last 4 weeks or who are presenting the following symptoms: dry or productive cough, sneezing, runny nose, body pain , headache, anosmia (loss of smell), ageusia (loss of taste) and/or any other symptom that may be related to covid-19 at the discretion of the investigator;
Participant who belongs to the risk group for COVID-19, that is, with cardiovascular, renal and chronic respiratory problems, immunosuppressed or other conditions that the doctor judges as belonging to the risk group;
Participants with heart disease (eg, but not limited to: atrial fibrillation, obstructive coronary artery disease);
Participants with renal and/or neurological diseases;
Participants with severe or decompensated lung and/or respiratory diseases;
Use of corticosteroids, antihistamines and/or anti-inflammatory drugs;
Presence of localized or generalized skin diseases;
Presence of active inflammatory dermatoses in the test region;
Frequent exposure to the sun or tanning beds;
Have participated in an allergenicity study within a period of less than four weeks from the beginning of the study;
Research participants with a history of allergy to the material used in the study;
Atopy history;
History of pathologies aggravated or triggered by ultraviolet radiation;
Immunodeficiency carriers;
Forecast of intense sun exposure or tanning session during the study period;
Forecast to take a bath in the sea, swimming pool or sauna during the study;
Research participants who practice water sports;
Research participants with dermographism;
Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticosteroids up to 2 weeks before selection;
Treatment with acidic vitamin A and/or its derivatives orally or topically up to 1 month before the start of the study;
Aesthetic and/or dermatological body treatment up to 03 weeks before selection;
Vaccination forecast during the study or up to 03 weeks before the study;
Any condition not mentioned above that, in the opinion of the investigator, could 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 families.
Be participating in some other study at the moment.
Any condition that, in the opinion of the researcher, could compromise the study.
Facility Information:
Facility Name
Kosmoscience Ciência e Tecnologia Cosmética Ltda
City
Campinas
State/Province
SP
ZIP/Postal Code
13041-315
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization of Hyaluronic Nasal Spray
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