Photosensitivity Disorders Clinical Trial
— MMPOfficial title:
Conventional Microneedling Compared to Microneedling Associated With 5-FU Infusion (Microinfusion of Medication Into the Skin - MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation
NCT number | NCT02904564 |
Other study ID # | 001 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 20, 2016 |
Est. completion date | January 2020 |
Verified date | July 2019 |
Source | Clinica Dermatologica Arbache ltda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Clinica Dermatologica Arbache Ltda | São José Dos Campos | SÃO Paulo |
Lead Sponsor | Collaborator |
---|---|
Clinica Dermatologica Arbache ltda |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lesions counting of Idiopathic Guttate Hypomelanosis (IGH) | Two assessors will independently count the number of lesions in the treated skin area | 30 days | |
Secondary | Patient satisfaction assessed by Likert scale | self-administered | 30 days | |
Secondary | Local adverse events | Frequency of patients presenting at least one local adverse event (ex:intense pain, scars, infection) | 30 days | |
Secondary | Systemic adverse events | Frequency of patients presenting at least one systemic adverse event (anaphylactic reaction) | 24 hours |
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