Sensitivity, ContactNCT04248556
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization
A study testing Health care product in people with 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 will be conducted with 92 subjects, aged 18 to 59 years. The product will be applied on the right and/or left back of the research participants for 3 consecutive weeks. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity, Contact
- What is being tested?
- Health care product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Mar 2021to 17 Apr 2021
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agreement to comply with safety guidelines to minimize contamination risks to COVID-19;
- Agreement to perform a molecular test to detect COVID-19 to enter the study;
- Healthy participants;
- Non-injured skin in the test region;
- Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations;
- ability to consent to participation in the study;
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- Age from 18 to 59 years;
- Phototype (Fitzpatrick): I to IV;
- All sex.
Who cannot join
- Participants who belong to the risk group for COVID-19, that is, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the doctor deems to belong to the risk group;
- Pregnant or breastfeeding women;
- Skin marks in the experimental area that interfere with the evaluation of possible skin reactions;
- Active dermatoses;
- Background of allergic reactions, irritation or intense discomfort sensations to topical use products;
- History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.);
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- Sensation of discomfort with temperature changes (too hot/very cold) and/or when in the air conditioning;
- Participants with a history of allergy to materials used in the study;
- History of pathologies aggravated or triggered by ultraviolet radiation;
- Carriers of immunodeficiencies;
- Intense sun exposure or tanning session up to 15 days before the initial evaluation;
- Prediction of intense sun exposure or tanning session during the course of the study;
- Expected to bathe in the sea, pool or bathtub during the conduct of the study;
- Participants who practice water sports;
- Dermography;
- Aesthetic and/or body dermatological treatment until 03 weeks before the selection;
- Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids until 2 weeks before selection or, considering deposit corticoids, the interval shall be 1 month before selection;
- Treatment with acidic vitamin A and/or its derivatives via oral or topical up to 1 month before the start of the study;
- Vaccination during the study or up to 3 weeks before the study;
- Being or having participated in another clinical trial terminated less than 7 days before selection, if the previous trial is acceptable in use;
- Being or having participated in another clinical trial terminated less than 21 days before the selection, in case the previous trial is compatible or Adverse Reaction investigative;
- Any condition not mentioned above that, in the opinion of the investigator, may compromise the assessment of the trial;
- History of no adherence or unwillingness to adhere to the study protocol;
- Professionals directly involved in the conduct of this protocol and their families.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, São Paulo, 13084-791
About this study
Official title: Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization Under Controlled and Maximised Conditions
This is a clinical study for health care product safety assessment. The research will be conducted with 92 subjects, aged 18 to 59 years. The product will be applied on the right and/or left back of the research participants for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 48 hours. Medical evaluation will be available throughout the study to assess possible adverse events.
The objective 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.
Read the detailed description
92 subjects, aged 18 to 59 years, phototypes I to IV (according to Fitzpatrick classification). The patch test will be used to verify the absence of primary and cumulative dermal irritation reactions and sensitization allergic reactions by the investigational products. The products will be applied as they are over semi-occlusive dressings.
- Conditions
- Sensitivity, Contact
- Being tested
- Health care product
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health care productOther
Health care product (gel) - to be applied on the participant's skin
| Study group | Role | What they receive |
|---|---|---|
| subjects, 18-59 y, healthy | Experimental | patch test with investigation product Receives: Other: Health care product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence
Absence of the occurrence of reactions of primary, accumulated dermal irritation and of allergic reactions by sensitization by the investigational products.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start9 Mar 2021
- Primary completion17 Apr 2021
- Study completion17 Apr 2021
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trial, single-arm
- Masking
- None (open label)
- Enrolment
- 69 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
- NCT04248556
- Sponsor's protocol ID
- All-S-RIPT-SO-PAD-074832
- Status last verified
- May 2021
- First submitted
- 28 Jan 2020
- Last updated
- 10 May 2021
- 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 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization Under Controlled and Maximised Conditions
- ClinicalTrials.gov ID
- NCT04248556
- Acronym / sponsor ID
- All-S-RIPT-SO-PAD-074832
- Conditions
- Sensitivity, Contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Herbarium Laboratorio Botanico LtdaIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 17 Apr 2021 (actual)
- Study completion
- 17 Apr 2021 (actual)
- First posted
- 30 Jan 2020 (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 will be conducted with 92 subjects, aged 18 to 59 years. The product will be applied on the right and/or left back of the research participants for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 48 hours. Medical evaluation will be available throughout the study to assess possible adverse events.
The objective 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.
Detailed description
92 subjects, aged 18 to 59 years, phototypes I to IV (according to Fitzpatrick classification). The patch test will be used to verify the absence of primary and cumulative dermal irritation reactions and sensitization allergic reactions by the investigational products. The products will be applied as they are over semi-occlusive dressings.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trial, single-arm
| Arm | Type | Receives |
|---|---|---|
| subjects, 18-59 y, healthy | Experimental | Other: Health care productpatch test with investigation product |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Agreement to comply with safety guidelines to minimize contamination risks to COVID-19;
- Agreement to perform a molecular test to detect COVID-19 to enter the study;
- Healthy participants;
- Non-injured skin in the test region;
- Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations;
Key exclusion criteria (24 listed)
- Participants who belong to the risk group for COVID-19, that is, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the doctor deems to belong to the risk group;
- Pregnant or breastfeeding women;
- Skin marks in the experimental area that interfere with the evaluation of possible skin reactions;
- Active dermatoses;
- Background of allergic reactions, irritation or intense discomfort sensations to topical use products;
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 |
|---|---|---|
| Health care productHealth care product (gel) - to be applied on the participant's skin | Other | subjects, 18-59 y, healthy |
Primary outcome
Absence
Time frame: 4 weeks
Absence of the occurrence of reactions of primary, accumulated dermal irritation and of allergic reactions by sensitization by the investigational products.
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 10 May 2021.
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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 Health care product 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 24 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 10 May 2021. 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: 4 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 10 May 2021.