Photosensitivity DisordersPhase 4MMPNCT02904564
Conventional Microneedling vs Microneedling With 5-FU (MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation
A Phase 4 study testing MMP with 5-FU and MMP with Saline infusion in people with Photosensitivity Disorders, run by Clinica Dermatologica Arbache ltda at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Photosensitivity Disorders
- What is being tested?
- MMP with 5-FU and MMP with Saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2016to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinica Dermatologica Arbache Ltda
São José dos Campos, São Paulo, 12245 760
SAMIR ARBACHE, +55 12 39221400, samir@dermocentro.com.br
About this study
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
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.
Read the detailed description
Split body design. Each upper limb will receive a different intervention (experimental or placebo)
- Conditions
- Photosensitivity Disorders
- Being tested
- MMP with 5-FU, MMP with Saline infusion
- Keywords
- drug delivery, Idiopathic Guttate Hypomelanosis
- Medical subject headings
- Photosensitivity Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMP with 5-FUDrug
Also called 5-fluorouracil, drug delivery, drug infusion, microinfusion of medication percutaneously
MMP with 5-FU using tattoo device
MMP with Saline infusionDrug
Also called MMP
MMP with saline infusion using tattoo device
| Study group | Role | What they receive |
|---|---|---|
| MMP with 5-FU infusion | Experimental | MMP with 5-FU infusion using tattoo device Receives: Drug: MMP with 5-FU |
| MMP with saline infusion | Placebo comparator | MMP with saline infusion using tattoo device Receives: Drug: MMP with Saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesions counting of Idiopathic Guttate Hypomelanosis (IGH)
Two assessors will independently count the number of lesions in the treated skin area
Measured: 30 days
Secondary outcomes (3)
Patient satisfaction assessed by Likert scale
self-administered
Measured: 30 days
Local adverse events
Frequency of patients presenting at least one local adverse event (ex:intense pain, scars, infection)
Measured: 30 days
Systemic adverse events
Frequency of patients presenting at least one systemic adverse event (anaphylactic reaction)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start20 Aug 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Photosensitivity DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Dermatologica Arbache ltda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904564
- Sponsor's protocol ID
- 001
- Acronym
- MMP
- Status last verified
- Jul 2019
- First submitted
- 26 Aug 2016
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37011024
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02904564
- Acronym / sponsor ID
- MMP / 001
- Conditions
- Photosensitivity Disorders
- Keywords
- drug delivery, Idiopathic Guttate Hypomelanosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Clinica Dermatologica Arbache ltdaUniversity, hospital or other
- Study start
- 20 Aug 2016 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMP with 5-FU infusion | Experimental | Drug: MMP with 5-FUMMP with 5-FU infusion using tattoo device |
| MMP with saline infusion | Placebo comparator | Drug: MMP with Saline infusionMMP with saline infusion using tattoo device |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMP with 5-FUAlso: 5-fluorouracil, drug delivery, drug infusion, microinfusion of medication percutaneouslyMMP with 5-FU using tattoo device | Drug | MMP with 5-FU infusion |
| MMP with Saline infusionAlso: MMPMMP with saline infusion using tattoo device | Drug | MMP with saline infusion |
Primary outcome
Lesions counting of Idiopathic Guttate Hypomelanosis (IGH)
Time frame: 30 days
Two assessors will independently count the number of lesions in the treated skin area
3 secondary outcomes
Patient satisfaction assessed by Likert scale
Time frame: 30 days
Local adverse events
Time frame: 30 days
Systemic adverse events
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Derived from this study: PubMed 37011024Arbache 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinica Dermatologica Arbache Ltda
São José dos Campos, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MMP with 5-FU and MMP with Saline infusion in people with Photosensitivity Disorders, run by Clinica Dermatologica Arbache ltda at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesions counting of Idiopathic Guttate Hypomelanosis (IGH) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02904564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.