Bleomycin Infusion (MMP®) to Repigment Achromic Scars

NCT04046679 | Unknown Phase 4

• 1 other identifier: 002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This intervention, called MMP®, is a procedure whereby drugs are injected through tattoo machines.

Conditions

SCAR

Keywords

MMP; DRUG DELIVERY; BLEOMYCIN; PIGMENTATION DISORDERS

Outcome Measures

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

  Measured at baseline and up to four months after treatment

Secondary Outcomes (1)

• Treatment-Emergent Adverse Events of bleomycin infusion into the skin

  11 monts

Study Arms (2)

Bleomycin

EXPERIMENTAL

Bleomycin Infusion By Tattoo Machine

Drug: Bleomycin; Other: Saline Solution

Saline Solution

PLACEBO COMPARATOR

Saline Infusion by Tattoo Machine

Drug: Bleomycin; Other: Saline Solution

Interventions

Bleomycin DRUG

Skin bleomycin infusion through tattoo machine

Bleomycin; Saline Solution

Saline Solution OTHER

Saline solution infusion through tattoo machine

Bleomycin; Saline Solution

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Dermatologica Arbache ltda: lead
• Traderm: collaborator

Study Sites (1)

Clinica Dermatologica Arbache Ltda

São José dos Campos, São Paulo, 12245 760, Brazil

Location

MeSH Terms

Conditions

Cicatrix; Pigmentation Disorders

Interventions

Bleomycin; Saline Solution

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

SAMIR ARBACHE

CONTACT

+5512981221011; samir@dermocentro.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will be done by throwing a coin
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 6, 2019
• Study Start: August 31, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)