Bleomycin Infusion (MMP®) to Repigment Achromic Scars

SCAR Clinical Trial

— MMP®  

Official title:

Bleomycin Infusion (MMP®) to Repigment Achromic Scars

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04046679
• Other study ID #: 002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 31, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: August 2019
• Source: Clinica Dermatologica Arbache ltda
• Contact: SAMIR ARBACHE
• Phone: +5512981221011
• Email: samir[@]dermocentro.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• SCAR

Intervention

Drug:
• Bleomycin
Skin bleomycin infusion through tattoo machine

Other:
• Saline Solution
Saline solution infusion through tattoo machine

Locations

Country	Name	City	State
Brazil	Clinica Dermatologica Arbache Ltda	São José Dos Campos	SÃO Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Dermatologica Arbache ltda	Traderm

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment-Emergent Adverse Events of bleomycin infusion into the skin	Treatment-Emergent Adverse Events assessment through clinical follow-up and photographic documentation	11 monts