Conventional Microneedling vs Microneedling With 5-FU (MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation

NCT ID: NCT02904564

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-20
• Study Completion Date: 2020-01-31

Brief Summary

The purpose of this study is to determine whether 5-FU infusion (Microinfusion of Medicine Percutaneously - MMP) is effective for Idiopathic Guttate Hypomelanosis (IGH) repigmentation compared to conventional Microneedling. MMP is a procedure done with tattoo devices using medication in place of ink.

Detailed Description

Split body design. Each upper limb will receive a different intervention (experimental or placebo)

Conditions

Photosensitivity Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MMP with 5-FU infusion

MMP with 5-FU infusion using tattoo device

Group Type: EXPERIMENTAL

MMP with 5-FU

Intervention Type: DRUG

MMP with 5-FU using tattoo device

MMP with saline infusion

MMP with saline infusion using tattoo device

Group Type: PLACEBO_COMPARATOR

MMP with Saline infusion

Intervention Type: DRUG

MMP with saline infusion using tattoo device

Interventions

MMP with 5-FU

MMP with 5-FU using tattoo device

Intervention Type: DRUG

MMP with Saline infusion

MMP with saline infusion using tattoo device

Intervention Type: DRUG

Other Intervention Names

5-fluorouracil; drug delivery; drug infusion; microinfusion of medication percutaneously; MMP; MMP

Eligibility Criteria

Inclusion Criteria

• Healthy males and females, between ages 30 and 70
• Photodamaged skin on upper limbs with IGH lesions meeting aforementioned criteria and excluding differential diagnosis
• Fitzpatrick skin types III - V
• Apt and willing to comply with the entire program as well as appointments, treatment and examination
• Capable of understanding and providing a written informed consent
• Fertile women will have to use a viable birth control method for at least 3 months prior to entry and throughout the entire study

Exclusion Criteria

• Pregnancy, intention to become pregnant during the course of the study, less than 3 months after delivery or less than 6 weeks after breastfeeding cessation.
• Uncontrolled comorbidity or any disease that, in the investigator's opinion, may interfere with the treatment, healing or cure.
• Present symptoms of hormonal disturbances, as per the investigator's criteria.
• Constitutional photosensitivity or due to metabolic disfunction, or due to use of external agentes (pharmaco, natural products, etc.) prior to initial treatment or during the study.
• Use of oral isotretinoin 6 months prior to initial treatment or during the course of the study.
• Prior treatment in target área 3 months prior to initial treatment or during the course of the study.
• Adverse reaction to any external agentes (gel, lotions or anesthetic creams) required during the study in case no alternative is available for such agent.
• History of keloids or other type of hypertrophic scar formation or poor wound healing in a previously injured area of skin.
• History of collagen disease.
• Displastic nevus or suspicious carcinogenic lesion in área to be treated.
• Hemmorragic disorder or under anticoagulant medication, including the use of aspirin not permitting a minimum 10-day suspension prior to each treatment period (in accordance with the criteria of the patient's physician).
• Skin frailty of sensitivity, favoring hemmorrage.
• History of immunosuppresion / immunological deficiency disorders (including HIV infection) or use of immunosuppressant medication.
• Participation in a study involving medication or another device three months prior to the study or during enrollment herein.
• Any condition which, in the investigator's opinion, would jeopardize the study or its participants, such as acute psychiatric disorders, panic syndrome or any aversion to needles or to the procedure.
• Hypochromiant dermatoses such as vitiligo, pitiriasis, versicolor, albinism.
• Dermatoses that evolve like Koebner's phenomenon.
• Cutaneous infectious process at the application site.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinica Dermatologica Arbache ltda

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinica Dermatologica Arbache Ltda

São José dos Campos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

SAMIR ARBACHE

Role: primary

samir@dermocentro.com.br

+55 12 39221400

References

Arbache S, Hirata SH. Efficacy and Safety of 5-Fluorouracil Tattooing to Repigment Idiopathic Guttate Hypomelanosis: A Split-Body Randomized Trial. Dermatol Surg. 2023 Jun 1;49(6):603-608. doi: 10.1097/DSS.0000000000003793. Epub 2023 Apr 3.

Reference Type: DERIVED

PMID: 37011024 (View on PubMed)

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id