Sensitivity, ContactNCT06723340
Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization of a Scar Gel
A study testing Scar gel in people with Sensitivity, Contact and Photosensitivity, run by Herbarium Laboratorio Botanico Ltda at 1 site in Brazil.
Trial summary
Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability, Dermal Sensitization, Photoallergy and Photosensitization, 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, Photosensitivity, Phototoxicity
- What is being tested?
- Scar gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Jan 2025to 20 Feb 2025
- 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
- Participants of both sexes aged 18 to 70 years;
- Phototypes: I, II, III, and IV (For the phototest trial, only phototypes II and III will be considered);
- Intact skin in the application area;
- Willingness to follow the trial procedures and attend the center on the specified dates and times for medical evaluations and for application and reading of dressings;
- Understanding, consent, and signing of the Informed Consent Form (ICF).
Who cannot join
- Pregnancy or risk of pregnancy/lactation;
- Use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months before selection;
- Immunosuppression due to drugs or active diseases;
- Uncompensated endocrinopathies;
- Personal history of atopy;
- Intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period;
Show all 27Show fewer
- Plans to bathe in the sea, pool, or sauna during the study;
- Practice of water sports during the study;
- Dermographism;
- Use of oral or topical treatments with vitamin A acid and/or its derivatives up to one month before the start of the study;
- Aesthetic and/or dermatological treatments on the body within three weeks prior to selection;
- Scheduled vaccination during the study period or within three weeks prior to selection;
- History of sensitization, irritation, or photosensitization to topical products;
- Active skin conditions (local and/or widespread) that could interfere with study results;
- Skin reactivity;
- Use of new medications during the study;
- Previous participation in studies with the same product;
- Congenital or acquired immunodeficiency;
- Clinically significant or current evidence of alcohol or drug abuse;
- Known or suspected history of intolerance to any ingredient in the study product;
- History of non-adherence or unwillingness to adhere to the study protocol;
- Employees of Medcin or the sponsoring company involved in the study, or close family members of an employee involved in the study;
- Other conditions deemed reasonable by the researcher for disqualification from study participation. If applicable, this must be noted in the clinical record.
- Previous history of conditions exacerbated or triggered by ultraviolet radiation;
- Use of photosensitizing drugs;
- History or presence of photodermatoses;
- Personal or family history of skin cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization Under Normal Conditions and When Exposed to Sunlight of a Scar Gel
Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability, Dermal Sensitization, Photoallergy and Photosensitization, 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 55 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested, non-irritating, non-sensitizing, non-photoirritating and non-photosensitizing.
- Conditions
- Sensitivity, Contact, Photosensitivity, Phototoxicity
- Being tested
- Scar gel
- Medical subject headings
- Dermatitis, Contact, Photosensitivity Disorders, Dermatitis, Phototoxic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar gelDevice
Scar gel (medical device - topical application)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Scar gel Receives: Device: Scar gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence
Absence of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization under normal conditions and when exposed to sunlight.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start13 Jan 2025
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
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
- 55 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
- NCT06723340
- Sponsor's protocol ID
- ORC-137110_EN24-0262-01_02
- Status last verified
- Mar 2025
- First submitted
- 4 Dec 2024
- Last updated
- 14 Mar 2025
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization Under Normal Conditions and When Exposed to Sunlight of a Scar Gel
- ClinicalTrials.gov ID
- NCT06723340
- Acronym / sponsor ID
- ORC-137110_EN24-0262-01_02
- Conditions
- Sensitivity, Contact, Photosensitivity, Phototoxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Herbarium Laboratorio Botanico LtdaIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 9 Dec 2024 (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, Dermal Sensitization, Photoallergy and Photosensitization, 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 55 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested, non-irritating, non-sensitizing, non-photoirritating and non-photosensitizing.
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 | Device: Scar gelScar gel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants of both sexes aged 18 to 70 years;
- Phototypes: I, II, III, and IV (For the phototest trial, only phototypes II and III will be considered);
- Intact skin in the application area;
- Willingness to follow the trial procedures and attend the center on the specified dates and times for medical evaluations and for application and reading of dressings;
- Understanding, consent, and signing of the Informed Consent Form (ICF).
Key exclusion criteria (27 listed)
- Pregnancy or risk of pregnancy/lactation;
- Use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months before selection;
- Immunosuppression due to drugs or active diseases;
- Uncompensated endocrinopathies;
- Personal history of atopy;
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 |
|---|---|---|
| Scar gelScar gel (medical device - topical application) | Device | Experimental |
Primary outcome
Absence
Time frame: 9 weeks
Absence of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization under normal conditions and when exposed to sunlight.
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 14 Mar 2025.
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 Scar gel in people with Sensitivity, Contact and Photosensitivity, 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 5 inclusion and 27 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 14 Mar 2025. 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: 9 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 14 Mar 2025.