Clinical trial NCT02904564: Conventional Microneedling vs Microneedling With 5-FU (MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation
Official title: Conventional Microneedling Compared to Microneedling Associated With 5-FU Infusion (Microinfusion of Medication Into the Skin - MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Photosensitivity Disorders
Keywords: drug delivery
Idiopathic Guttate Hypomelanosis
Lead sponsor: Clinica Dermatologica Arbache ltda
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Lesions counting of Idiopathic Guttate Hypomelanosis (IGH)
timeFrame: 30 days
Secondary outcomes:
measure: Patient satisfaction assessed by Likert scale
timeFrame: 30 days
measure: Local adverse events
timeFrame: 30 days
measure: Systemic adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: São José Dos Campos
country: Brazil
facility: Clinica Dermatologica Arbache Ltda
state: SÃO Paulo
Study officials:
References: