Bleomycin Infusion (MMP®) to Repigment Achromic Scars (MMP®)

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

Study Overview

• Status: Unknown
• Conditions: SCAR
• Intervention / Treatment: Drug: Bleomycin; Other: Saline Solution

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SÃO Paulo
    • São José Dos Campos, SÃO Paulo, Brazil, 12245 760
      • Clinica Dermatologica Arbache ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bleomycin; Bleomycin Infusion By Tattoo Machine	Drug: Bleomycin; Skin bleomycin infusion through tattoo machine; Other: Saline Solution; Saline solution infusion through tattoo machine
Placebo Comparator: Saline Solution; Saline Infusion by Tattoo Machine	Drug: Bleomycin; Skin bleomycin infusion through tattoo machine; Other: Saline Solution; Saline solution infusion through tattoo machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-Emergent Adverse Events of bleomycin infusion into the skin	Treatment-Emergent Adverse Events assessment through clinical follow-up and photographic documentation	11 monts

Collaborators and Investigators

• Sponsor: Clinica Dermatologica Arbache ltda
• Collaborators: Traderm

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2019
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: MMP; DRUG DELIVERY; BLEOMYCIN; PIGMENTATION DISORDERS
• Additional Relevant MeSH Terms: Antineoplastic Agents; Antibiotics, Antineoplastic; Bleomycin
• Other Study ID Numbers: 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No