conventional microneedling vs microneedling with 5-fu (mmp) for idiopathic guttate hypomelanosis (igh) repigmentation

Conditions: Photosensitivity Disorders

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.

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.

Keywords: drug delivery idiopathic guttate hypomelanosis