An interventional study of Microneedling in Acquired Hypomelanosis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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:
▪Patients, both genders and older than 18 years with localized acquired hypomelanosis
Excluding:
Methodology in details:
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
10 studies on the registry are indexed under Hypopigmentation; 2 are open to participants now.
Browse Hypopigmentation studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Hypopigmentation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pigmentation Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
microneedling.
Procedure: Microneedling
No treatment will be done to these hypopigmented lesions
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).
Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning.
drawing the lesion's surface area through transparent stencil paper
Time frame: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning
using hue skin tone color scale
Time frame: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by vitiligo extent score for a target area for marginal and perifollicular repigmentation.
The repigmentation assessed by percentage value range from 0- 100% where the 100 % means full repigmentation, the value is a result of an equation where the estimated percentage of marginal repigmentation add to ( remaining area (%) plus estimated percent of perifollicular pigmentation in the remaining area(%) divided by 100)
Time frame: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by the patient's satisfaction score
3-point scale (not satisfied, moderately satisfied, extremely satisfied).
Time frame: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by patient global percent of his own improvement(0-100%).
the patient evaluation to lesion by percentage value for repigmentation ranged from 0- 100% which represent full repigmentation.
Time frame: 3 months post treatment
Efficacy of microneedling for acquired hypomelanosis assessed by mean physician's global assessment for percent of improvement (0-100%).
One unblinded and 2 blinded investigators assessed the global improvement through photographs of the lesions before and after 3 months of therapy. The lesions were photographed on a black background using a single reflex camera with standardized settings (ambient light, same position, and distance from the patient).
Time frame: 3 moonths post treatment.
Incidence of microneedling adverse events
Safety as defined by occurrence of pain, bleeding, local infection, skin flaking, and scarring during, shortly after the procedure (2weeks), and at the end of the study.
Time frame: Day 1 to 14 and after 3 months.
Plan to share: No
Ran from Sep 2019 to primary completion in Apr 2020, 6 months.
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