Evaluation of Cutaneous Acceptability and Perceived Effectiveness of a Nasal Spray (Health Care Products)

Clinical Study to Evaluate the Safety of the Investigational Product NASAL SPRAY Through of Assessments of Cutaneous Acceptability and Perceived Efficacy Under Normal Conditions of Use

This 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.

Study Overview

• Status: Completed
• Conditions: Acceptance, Social; Sensitivity, Contact
• Intervention / Treatment: Other: Hyaluronic Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil, 13041-315
      • Kosmoscience Ciência e Tecnologia Cosmética Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Phototype (Fitzpatrick): I to VI.
• User of the same product category.
• Have intact skin in the study region.
• Agree to adhere to the study procedures and requirements: study time, returns (after 28 days) to the laboratory to perform the study procedures, home use of the investigational product, filling in the use diary, not changing facial cosmetic habits during the period of study.
• Agree not to perform facial aesthetic dermatological treatments until the end of the study (28 days), such as: peelings, laser, fillers, use of any facial cosmetics.
• 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.
• Signing of the Free and Informed Consent Term (FICT).

Exclusion Criteria:

• Pregnant or lactating women.
• Skin tags in the experimental area that interfere in the assessment of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, large amounts of freckles and warts, sunburn).
• Presence of active dermatoses or skin lesions (local and/or disseminated) in the study region.
• Carriers of corneal ulcerations, keratoconus, blepharitis, meibomitis, pterygium, chemosis, hyperemia or other active eye diseases of moderate or severe intensity.
• History of ineffectiveness, allergic reactions, irritation or intense discomfort sensation to topical products: cosmetics or medicines.
• Expected vaccination during the study or up to 3 weeks before the study;
• History of pathologies aggravated or triggered by ultraviolet radiation.
• Use of non-steroidal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizers or immunosuppressants up to 2 weeks before the study.
• Facial aesthetic or dermatological treatment up to 4 weeks before the study.
• Hormonal treatments not stable in the last 3 months.
• Hyperpigmentation associated with the use of drugs such as tetracycline, phenothiazides, or amiodarone.
• Hyperpigmentation associated with photosensitivity.
• Actinic lichen planus;
• People directly involved in carrying out this study and their families.
• Be participating in another study.
• History of non-adherence or unwillingness to adhere to the study protocol.
• Intense sun exposure or tanning session up to 15 days before the initial assessment;
• Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Other: Hyaluronic Nasal Spray; Health care product - nasal application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema degree or absence	Erythema evaluation according to International Contact Dermatitis Research Group	28 days

Collaborators and Investigators

• Sponsor: Herbarium Laboratorio Botanico Ltda

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Contact
• Other Study ID Numbers: HB2053-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No