Acquired Hypomelanosis Clinical Trial
Official title:
Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial
Acquired hypomelanosis is a type of cutaneous melanocytopenic hypomelanosis, denoting the
lightening of the skin due to a reduction in the number of epidermal and/or follicular
melanocytes secondary to physical agents,post-inflammatory, and iatrogenic (steroids).
Derma roller is the basic device of microneedling , performs superficial, controlled
puncturing of the skin by rolling with miniature fine needles and used as a collagen
induction therapy and a transdermal delivery system for therapeutic drugs and vaccines.
This minute trauma to the skin that activates regenerative mechanisms and wound healing by
releasing growth factors. The release of cytokines and deposition of hemosiderin from dermal
bleeding induce the activation of melanocyte and stimulate skin pigmentation plus transdermal
traveling of melanocyte
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:
â–ªPatients, 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
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