Acceptance, SocialNCT05508230
Evaluation of Cutaneous Acceptability and Perceived Effectiveness of a Nasal Spray (Health Care Products)
A study testing Hyaluronic Nasal Spray in people with Acceptance, Social and Sensitivity, Contact, run by Herbarium Laboratorio Botanico Ltda at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acceptance, Social, Sensitivity, Contact
- What is being tested?
- Hyaluronic Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 15 May 2023to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Kosmoscience Ciência e Tecnologia Cosmética Ltda
Campinas, São Paulo, 13041-315
About this study
Official title: 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.
- Conditions
- Acceptance, Social, Sensitivity, Contact
- Being tested
- Hyaluronic Nasal Spray
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Nasal SprayOther
Health care product - nasal application
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Other: Hyaluronic Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema degree or absence
Erythema evaluation according to International Contact Dermatitis Research Group
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start15 May 2023
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptance, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbarium Laboratorio Botanico Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508230
- Sponsor's protocol ID
- HB2053-23
- Status last verified
- Jul 2023
- First submitted
- 18 Aug 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05508230
- Acronym / sponsor ID
- HB2053-23
- Conditions
- Acceptance, Social, Sensitivity, Contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Herbarium Laboratorio Botanico LtdaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Hyaluronic Nasal Spray |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Nasal SprayHealth care product - nasal application | Other | Experimental |
Primary outcome
Erythema degree or absence
Time frame: 28 days
Erythema evaluation according to International Contact Dermatitis Research Group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Quality of Life
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Nasal Spray in people with Acceptance, Social and Sensitivity, Contact, run by Herbarium Laboratorio Botanico Ltda at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema degree or absence (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.