Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization of Hyaluronic Nasal Spray

NCT05508243 | Completed

• 1 other identifier: HB053-22
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensitivity, Contact

Outcome Measures

Primary Outcomes (1)

• Absence

  Absence occurence of phototoxicity and photoallergy

  6 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Other: Hyaluronic Nasal Spray

Interventions

Hyaluronic Nasal Spray OTHER

Health care product - nasal application

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Herbarium Laboratorio Botanico Ltda: lead

Study Sites (1)

Kosmoscience Ciência e Tecnologia Cosmética Ltda

Campinas, São Paulo, 13041-315, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 19, 2022
• Study Start: October 17, 2022
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

BR (1)