SCARPhase 4MMP®NCT04046679
Bleomycin Infusion (MMP®) to Repigment Achromic Scars
A Phase 4 study testing Bleomycin and Saline Solution in people with SCAR, run by Clinica Dermatologica Arbache ltda at 1 site in Brazil.
Trial summary
This intervention, called MMP®, is a procedure whereby drugs are injected through tattoo machines. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- SCAR
- What is being tested?
- Bleomycin and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Aug 2019to 31 Aug 2020
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy men and women between 20 and 60 years old.
- Be able and willing to comply with all programming and requirements for visits, treatment and evaluation.
- Can understand and provide written informed consent.
- Women of childbearing age will be required to use a viable and effective method of birth control at least 3 months before and after study participation and throughout the course of the study.
- Prior hematological, hepatic and renal laboratory evaluation proving integrity of these organs, in addition to negative pregnancy test.
- If the participant is referred by another doctor, they should obtain a letter of authorization to participate in this trial.
Who cannot join
- Bleomycin is contraindicated for patients who show hypersensitivity or idiosyncratic reaction to the referred drug
- Patients using brentuximab or cyclophosphamide, which may result in increased risk of pulmonary toxicity
- Patients undergoing oxygen therapy, radiotherapy, antineoplastic drug therapy.
- Pregnancy. Fertile women should simultaneously use two contraceptive methods, for example contraceptives and condoms.
- Breast-feeding.
- Lung disease or history.
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- "Bone Marrow Diseases"
- "Patients with compromised nutritional status"
- "Patients with proven and serious blood problems"
- "Severe infection"
- "Patients undergoing major surgery"
- Participants with non-randomizable scars, for example, will be excluded from the study participants with few lesions smaller than 1.0 cm. or patients with scars with complex morphology, difficult to randomize, will be excluded from the study.
- Scars with dimensions greater than 1% of body area.
- Patients extremely sensitive to pain or intolerant to any type of skin intervention.
- Less than 3 months after birth or less than 6 weeks after breastfeeding has ended.
- Decompensated comorbidity or any disease that, in the opinion of the investigator, may interfere with treatment, healing or cure.
- Have a bleeding disorder or use anticoagulants, including aspirin (at least 10 days of anticoagulant withdrawal).
- Sensitivity or skin fragility, favor bleeding.
- History of immunosuppression / immune deficiency disorders (including HIV infection).
- Any condition that, in the opinion of the investigator, is unsafe for participants, such as acute psychiatric disorders, panic syndrome or any aversion to needles or the procedure.
- Infectious process at the application site.
- Scars from infectious processes, e.g. herpes simplex, herpes zoster, chickenpox, cutaneous leishmaniasis, or any scarring secondary to infectious pathology.
- Clinically thickened achromic scars.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinica Dermatologica Arbache Ltda
São José dos Campos, São Paulo, 12245 760
About this study
This intervention, called MMP®, is a procedure whereby drugs are injected through tattoo machines.
Read the detailed description
Treatment consists of Bleomycin infusion (3.0 U/ml) compared to saline infusion (parallel treatment).
Results will be evaluated after a maximum of 7 treatments, through clinical evaluation and Antera equipment analyze.
Laboratory tests are being requested to verify hematologic, renal and hepatic integrity.
The treatment will be double blind, one side of the scar will be treated with bleomycin and the other side saline infusion.
The test will consist of 5 subgroups of scars:
- Subgroup 1 - Postoperative achromic scars. N1 = 10 participants
- Subgroup 2 - post-laser therapy achromic scars. N2 = 10 participants
- Subgroup 3 - achromic scars after non-laser ablative treatments. N3 = 10 participants
- Subgroup 4 - Posttraumatic achromic scars. N4 = 10 participants
- Subgroup 5 - achromic scars after phenol therapy. N5 = 10 participants
Therefore, the total will be 50 participants.
- Conditions
- SCAR
- Being tested
- Bleomycin, Saline Solution
- Keywords
- MMP, DRUG DELIVERY, BLEOMYCIN, PIGMENTATION DISORDERS
- Medical subject headings
- Cicatrix, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BleomycinDrug
Skin bleomycin infusion through tattoo machine
Saline SolutionOther
Saline solution infusion through tattoo machine
| Study group | Role | What they receive |
|---|---|---|
| Bleomycin | Experimental | Bleomycin Infusion By Tattoo Machine Receives: Drug: Bleomycin; Other: Saline Solution |
| Saline Solution | Placebo comparator | Saline Infusion by Tattoo Machine Receives: Drug: Bleomycin; Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of melanin in the achromic scars (scar repigmentation)
Investigators will use antera device to measure the level of melanin in the achromic scars and photografic documentation
Measured: Measured at baseline and up to four months after treatment
Secondary outcomes (1)
Treatment-Emergent Adverse Events of bleomycin infusion into the skin
Treatment-Emergent Adverse Events assessment through clinical follow-up and photographic documentation
Measured: 11 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start31 Aug 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCARStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Scars or scarring areas will be randomized. Some scars or areas of scars will be infused with Bleomycin by tattoo machine and other scars or areas of scars will be infused with saline also by tattoo machine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Dermatologica Arbache ltda
- Sponsor type
- University, hospital or other
- Collaborators
- Traderm
- Responsible party
- Principal investigator, SAMIR ARBACHE, Clinica Dermatologica Arbache ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046679
- Sponsor's protocol ID
- 002
- Acronym
- MMP®
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleomycin Infusion (MMP®) to Repigment Achromic Scars
- ClinicalTrials.gov ID
- NCT04046679
- Acronym / sponsor ID
- MMP® / 002
- Conditions
- SCAR
- Keywords
- MMP, DRUG DELIVERY, BLEOMYCIN, PIGMENTATION DISORDERS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clinica Dermatologica Arbache ltdaUniversity, hospital or other
- Collaborators
- Traderm
- Study start
- 31 Aug 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 6 Aug 2019 (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 intervention, called MMP®, is a procedure whereby drugs are injected through tattoo machines.
Detailed description
Treatment consists of Bleomycin infusion (3.0 U/ml) compared to saline infusion (parallel treatment).
Results will be evaluated after a maximum of 7 treatments, through clinical evaluation and Antera equipment analyze.
Laboratory tests are being requested to verify hematologic, renal and hepatic integrity.
The treatment will be double blind, one side of the scar will be treated with bleomycin and the other side saline infusion.
The test will consist of 5 subgroups of scars:
- Subgroup 1 - Postoperative achromic scars. N1 = 10 participants
- Subgroup 2 - post-laser therapy achromic scars. N2 = 10 participants
- Subgroup 3 - achromic scars after non-laser ablative treatments. N3 = 10 participants
- Subgroup 4 - Posttraumatic achromic scars. N4 = 10 participants
- Subgroup 5 - achromic scars after phenol therapy. N5 = 10 participants
Therefore, the total will be 50 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Scars or scarring areas will be randomized. Some scars or areas of scars will be infused with Bleomycin by tattoo machine and other scars or areas of scars will be infused with saline also by tattoo machine.
| Arm | Type | Receives |
|---|---|---|
| Bleomycin | Experimental | Drug: Bleomycin, Other: Saline SolutionBleomycin Infusion By Tattoo Machine |
| Saline Solution | Placebo comparator | Drug: Bleomycin, Other: Saline SolutionSaline Infusion by Tattoo Machine |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy men and women between 20 and 60 years old.
- Be able and willing to comply with all programming and requirements for visits, treatment and evaluation.
- Can understand and provide written informed consent.
- Women of childbearing age will be required to use a viable and effective method of birth control at least 3 months before and after study participation and throughout the course of the study.
- Prior hematological, hepatic and renal laboratory evaluation proving integrity of these organs, in addition to negative pregnancy test.
Key exclusion criteria (23 listed)
- Bleomycin is contraindicated for patients who show hypersensitivity or idiosyncratic reaction to the referred drug
- Patients using brentuximab or cyclophosphamide, which may result in increased risk of pulmonary toxicity
- Patients undergoing oxygen therapy, radiotherapy, antineoplastic drug therapy.
- Pregnancy. Fertile women should simultaneously use two contraceptive methods, for example contraceptives and condoms.
- Breast-feeding.
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 |
|---|---|---|
| BleomycinSkin bleomycin infusion through tattoo machine | Drug | Bleomycin, Saline Solution |
| Saline SolutionSaline solution infusion through tattoo machine | Other | Bleomycin, Saline Solution |
Primary outcome
Level of melanin in the achromic scars (scar repigmentation)
Time frame: Measured at baseline and up to four months after treatment
Investigators will use antera device to measure the level of melanin in the achromic scars and photografic documentation
1 secondary outcome
Treatment-Emergent Adverse Events of bleomycin infusion into the skin
Time frame: 11 monts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bleomycin and Saline Solution in people with SCAR, run by Clinica Dermatologica Arbache 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 6 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 6 Aug 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SAMIR ARBACHE (+5512981221011, samir@dermocentro.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of melanin in the achromic scars (scar repigmentation) (time frame: Measured at baseline and up to four months after treatment). 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 6 Aug 2019.