Microneedling for Acquired Hypomelanosis
Keywords
Abstract
Description
The aim of this study to evaluate the efficacy and safety of microneedling as a treatment model for patients with acquired hypomelanosis.
Patients with an acquired hypomelanosis from outpatient clinic, department of dermatology, Cairo university,n=20. including:
▪Patients, both genders and older than 18 years with localized acquired hypomelanosis
Excluding:
- Congenital and hereditary hypomelanosis.
- Vitiligo
- Pregnancy and lactation.
- Patients with a history of any autoimmune disease.
- Patients with a history of keloid formation.
- Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy.
Methodology in details:
- An informed written consent will be obtained from the patient or his legal guardian if he is younger than 21years old.
- For every patient detailed history will focus on the onset, course, duration of hypomelanosis, the type of insult, previous treatments, systemic illness and drug history. The examination will describe the anatomical site, size, degree of skin lightening, skin texture and presence or absence of hair in the affected area.
- The area to be treated will be specified and split into two halves then randomized into one of both arms: treatment or no treatment.
- One session of microneedling will be performed on the treatment arm by using dermaroller 1.5 mm long. The microneedling will be done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal).
- Patients will be then monitored for three months for signs of repigmentation.
- Patient's improvement will be objectively assessed monthly for repigmentation using patient's and physician's scales.
Possible Risk:
Pain, transient bleeding, erythema, mild edema and infection at the site of microneedling. Failure of treatment is also a possibility.
Primary outcomes:
Efficacy of microneedling for acquired hypomelanosis after 3 months.
Secondary outcome:
Safety as defined by the occurrence of adverse events during, shortly after the procedure (2weeks), and after 3 months.
Sample size(number of patients included):20 patients
Source of funding: self funding
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 05/22/2020 |
| Estimated Enrollment Submitted: | 06/02/2020 |
| First Posted: | 06/04/2020 |
| Last Update Submitted: | 06/03/2020 |
| Last Update Posted: | 06/08/2020 |
| Actual Study Start Date: | 09/14/2019 |
| Estimated Primary Completion Date: | 03/31/2020 |
| Estimated Study Completion Date: | 04/30/2020 |
Condition or disease
Intervention/treatment
Procedure: treatment
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: treatment microneedling. | Procedure: treatment One session of microneedling will be performed by using dermaroller 1.5 mm. The microneedling done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal). |
| No Intervention: No treatment No treatment will be done to these hypopigmented lesions |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Localized acquired hypomelanosis secondary to any insult, post-inflammatory or iatrogenic of no more than 2 years duration, affecting any anatomical site except genitalia, of any size larger than 3 cm in diameter. - Patients older than 18 years old, consenting to go through the microneedling procedure. - Both genders. Exclusion criteria: - Congenital and hereditary hypomelanosis. - Vitiligo - Pregnancy and lactation. - Patients with history of any autoimmune disease. - Patients with history of keloids formation. - Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy. |
Outcome
Primary Outcome Measures
1. Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning. [3 months post treatment]
2. Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning [3 months post treatment]
3. Efficacy of microneedling for acquired hypomelanosis assessed by vitiligo extent score for a target area for marginal and perifollicular repigmentation. [3 months post treatment]
4. Efficacy of microneedling for acquired hypomelanosis assessed by the patient's satisfaction score [3 months post treatment]
5. Efficacy of microneedling for acquired hypomelanosis assessed by patient global percent of his own improvement(0-100%). [3 months post treatment]
6. Efficacy of microneedling for acquired hypomelanosis assessed by mean physician's global assessment for percent of improvement (0-100%). [3 moonths post treatment.]
Secondary Outcome Measures
1. Incidence of microneedling adverse events [Day 1 to 14 and after 3 months.]
