Sensitivity, ContactNCT05508243
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization of Hyaluronic Nasal Spray
A study testing Hyaluronic Nasal Spray in people with Sensitivity, Contact, run by Herbarium Laboratorio Botanico Ltda at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity, Contact
- What is being tested?
- Hyaluronic Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Oct 2022to 24 Nov 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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).
Who cannot join
- 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;
Show all 29Show fewer
- 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.
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: Dermatologist-supervised Assessment of Primary and Accumulated Irritation Potential and Skin Sensitization Potential for the NASAL SPRAY Product
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
- 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.
Absence
Absence occurence of phototoxicity and photoallergy
Measured: 6 weeks
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 start17 Oct 2022
- Primary completion24 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity, ContactStudies 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
- 65 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
- NCT05508243
- Sponsor's protocol ID
- HB053-22
- Status last verified
- Mar 2023
- First submitted
- 18 Aug 2022
- Last updated
- 17 Mar 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 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatologist-supervised Assessment of Primary and Accumulated Irritation Potential and Skin Sensitization Potential for the NASAL SPRAY Product
- ClinicalTrials.gov ID
- NCT05508243
- Acronym / sponsor ID
- HB053-22
- Conditions
- Sensitivity, Contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Herbarium Laboratorio Botanico LtdaIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (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.
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.
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
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (29 listed)
- 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);
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
Absence
Time frame: 6 weeks
Absence occurence of phototoxicity and photoallergy
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 17 Mar 2023.
Related trials for Sensitivity, Contact
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Recruiting
Glycyrrhetinic Acid and Acute Irritant Dermatitis
Irritant Contact Dermatitis
Recruiting
Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis, and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes
Contact Dermatitis, Type 1 Diabetes Mellitus
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 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 9 inclusion and 29 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 17 Mar 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?
Absence (time frame: 6 weeks). 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 17 Mar 2023.