Acceptability StudyPhase 1/2NCT06751433
Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars
A Phase 1/2 study testing Scar gel and Scar gel comparator in people with Acceptability Study and Real-use Conditions, run by Herbarium Laboratorio Botanico Ltda at 2 sites in Brazil.
Trial summary
Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acceptability Study, Real-use Conditions, Safety and Efficacy
- What is being tested?
- Scar gel and Scar gel comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesBrazil
- Study dates
- 3 Apr 2025to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of both sexes aged between 18 and 70 years;
- Participants with recent scars (<30 days);
- Participants with phototypes III to VI according to the Fitzpatrick scale;
- Agree to follow the trial procedures and attend the center on the days and times determined for evaluations;
- Understand, agree to and sign the free and informed consent form.
- Types of scars: cesarean section, breast implant or blunt cut injury.
Who cannot join
- Pregnancy or risk of pregnancy;
- History of atopic or allergic reactions to cosmetic products;
- Participants who are using topical antibiotics or other skin products on the same area being evaluated;
- Immunosuppression due to drugs or active diseases;
- Decompensated endocrine diseases;
- Relevant clinical history or current evidence of alcohol or other drug abuse;
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- Known history or suspected intolerance to products in the same category;
- Intense sun exposure up to 15 days before the evaluation;
- Patients who are using topical antibiotics or other skin products on the same area being evaluated.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Medcin Instituto da Pele Ltda
Osasco, São Paulo
Flávia A. S. Addor, (55) 11 3683-5366, contato@medcinpesquisa.com.br
- Recruiting
MEDCIN
Osasco
Addor, (55) (11) 3683-5366, contato@medcinpesquisa.com.br
About this study
Official title: Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance
Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.
Read the detailed description
Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use. Comparison of the efficacy of the investigational product with the benchmark product in preventing hypertrophic scars and improving scar appearance, as well as analyzing parameters such as skin hydration, pruritus, discomfort, and normalization of scar pigmentation.
- Conditions
- Acceptability Study, Real-use Conditions, Safety and Efficacy, Topical Administration, Hypertrophic Scars, Keloid Scars
- Being tested
- Scar gel, Scar gel comparator
- Medical subject headings
- Cicatrix, Hypertrophic, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar gelDevice
Health care product (scar gel)
Scar gel comparatorDevice
Health care product (Scar gel comparator)
| Study group | Role | What they receive |
|---|---|---|
| Participants of both sexes, 18 - 70 y | Active comparator | Participants of both sexes, 18 - 70 y, who have recent scars. Receives: Device: Scar gel comparator |
| Exp.: Participants of both sexes, 18 - 70 y | Experimental | Participants of both sexes, 18 - 70 y, with recent scars Receives: Device: Scar gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clinical and perceived efficacy
Evaluate the prevention of hypertrophic scars after 90 days of continuous use of the investigational product. The dermatologist will perform assessments of the clinical parameters using the POSAS scale.
Measured: 90 days
Secondary outcomes (1)
Perceived efficacy
To compare the treatments of the benchmark product versus the investigational product in improving the appearance of scars, discomfort, skin hydration, itching and normalization of scar pigmentation, after 90 days of use, through a questionnaire on perceived efficacy.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start3 Apr 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptability StudyStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial, double arm, double blind, randomized
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
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
- NCT06751433
- Sponsor's protocol ID
- ORC-137032_EN-24-0252-01
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2024
- Last updated
- 11 Sep 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance
- ClinicalTrials.gov ID
- NCT06751433
- Acronym / sponsor ID
- ORC-137032_EN-24-0252-01
- Conditions
- Acceptability Study, Real-use Conditions, Safety and Efficacy, Topical Administration, Hypertrophic Scars, Keloid Scars
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Herbarium Laboratorio Botanico LtdaIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 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.
Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.
Detailed description
Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use. Comparison of the efficacy of the investigational product with the benchmark product in preventing hypertrophic scars and improving scar appearance, as well as analyzing parameters such as skin hydration, pruritus, discomfort, and normalization of scar pigmentation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial, double arm, double blind, randomized
| Arm | Type | Receives |
|---|---|---|
| Participants of both sexes, 18 - 70 y | Active comparator | Device: Scar gel comparatorParticipants of both sexes, 18 - 70 y, who have recent scars. |
| Exp.: Participants of both sexes, 18 - 70 y | Experimental | Device: Scar gelParticipants of both sexes, 18 - 70 y, with recent scars |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants of both sexes aged between 18 and 70 years;
- Participants with recent scars (<30 days);
- Participants with phototypes III to VI according to the Fitzpatrick scale;
- Agree to follow the trial procedures and attend the center on the days and times determined for evaluations;
- Understand, agree to and sign the free and informed consent form.
Key exclusion criteria (9 listed)
- Pregnancy or risk of pregnancy;
- History of atopic or allergic reactions to cosmetic products;
- Participants who are using topical antibiotics or other skin products on the same area being evaluated;
- Immunosuppression due to drugs or active diseases;
- Decompensated endocrine diseases;
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 gelHealth care product (scar gel) | Device | Exp.: Participants of both sexes, 18 - 70 y |
| Scar gel comparatorHealth care product (Scar gel comparator) | Device | Participants of both sexes, 18 - 70 y |
Primary outcome
Assessment of clinical and perceived efficacy
Time frame: 90 days
Evaluate the prevention of hypertrophic scars after 90 days of continuous use of the investigational product. The dermatologist will perform assessments of the clinical parameters using the POSAS scale.
1 secondary outcome
Perceived efficacy
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Scar gel and Scar gel comparator in people with Acceptability Study and Real-use Conditions, run by Herbarium Laboratorio Botanico Ltda at 2 sites 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flávia A. S. Addor ((55) 11 3683-5366, contato@medcinpesquisa.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of clinical and perceived efficacy (time frame: 90 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 11 Sep 2025.