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Status unknownNCT04046679MMP®Updated Aug 6, 2019

Bleomycin Infusion (MMP®) to Repigment Achromic Scars

A Phase 4 interventional study of Bleomycin and Saline Solution in SCAR, sponsored by Clinica Dermatologica Arbache ltda. Status unknown at 1 site in Brazil. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Clinica Dermatologica Arbache ltda · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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:

  1. Subgroup 1 - Postoperative achromic scars. N1 = 10 participants
  2. Subgroup 2 - post-laser therapy achromic scars. N2 = 10 participants
  3. Subgroup 3 - achromic scars after non-laser ablative treatments. N3 = 10 participants
  4. Subgroup 4 - Posttraumatic achromic scars. N4 = 10 participants
  5. Subgroup 5 - achromic scars after phenol therapy. N5 = 10 participants

Therefore, the total will be 50 participants.

02

Conditions studied

  • SCAR

Keywords

  • MMP
  • DRUG DELIVERY
  • BLEOMYCIN
  • PIGMENTATION DISORDERS
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • "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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Bleomycin

    Bleomycin Infusion By Tattoo Machine

    Drug: Bleomycin · Other: Saline Solution

  • Placebo comparator
    Saline Solution

    Saline Infusion by Tattoo Machine

    Drug: Bleomycin · Other: Saline Solution

Interventions

  • DrugBleomycin

    Skin bleomycin infusion through tattoo machine

  • OtherSaline Solution

    Saline solution infusion through tattoo machine

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 11 monts

06

Study locations

1 site
  • Clinica Dermatologica Arbache Ltda
    São José Dos Campos, SÃO Paulo 12245 760, Brazil
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04046679
Lead sponsor
Clinica Dermatologica Arbache ltda
Collaborators
Traderm
Responsible party
SAMIR ARBACHE (Principal Investigator, Clinica Dermatologica Arbache ltda) — Principal investigator
First posted
Aug 6, 2019
Start date
Aug 31, 2019 (estimated)
Primary completion
Aug 31, 2020 (estimated)
Completion
Aug 31, 2020 (estimated)
Last update
Aug 6, 2019

Study contacts

SAMIR ARBACHE
Contact
samir@dermocentro.com.br
+5512981221011

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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