Microneedle and Trichloroaceticacid in Treatment of Melasma

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Status

Sponsorer

Assiut University

KLINISK FORSØG: NCT03472235

BioSeek: nct03472235

Nøgleord

Abstrakt

Melasma is an acquired disorder of hyperpigmentation characterised by blotchy, light-to-dark brown macules distributed symmetrically on the sun-exposed parts of the body.

Although many factors have been proposed to have a role in pathogenesis, the exact ethology is yet to be understood. The most commonly identifiable risk factors include ultraviolet radiation, genetic predisposition, pregnancy, oral contraceptives, thyroid disease and drugs like antiepileptic. The excessive pigmentation has been attributed to both melanocytosis (increased number of melanocytes) as well as melano genesis (excess production of melanin) as confirmed in a histopathological study on Asian patients.] Furthermore, a vascular component has also been proposed to play a role in the pathogenesis of melisma. Kim et al. have found that lesion melasma skin had greater expression of the vascular endothelial growth factor in keratinocytes compared to nearby nonlesional skin.

Beskrivelse

As regards management, the therapeutic options range from photoprotection, topical hypopigmenting agents, chemical peels and lasers. There are variety of less-tried systemic agents like fish oil, green tea and . Although no single agent has proved to be effective for all patients, a combination of two or three agents is often tried to achieve optimum results.

Chemical peeling is the application of a chemical agent to the skin, which causes the controlled destruction of a part or of the entire epidermis, with or without the dermis, leading to exfoliation and removal of superficial lesions, followed by the regeneration of new epidermal and dermal tissues.

Chemical peels are a well-known modality of treatment for melasma. The basic mechanism of the action of chemical peels in melasma is the removal of unwanted melanin by causing a controlled chemical burn to the skin.

Trichlroacetic acid peeling has been the gold standard in chemical peeling for many decades.

For superficial peels Trichlroacetic acid 10% to 25% are used. some authors consider up to 35% Trichlroacetic acid as also a superficial.

Skin microneedling is a technique predominantly used to improve the appearance of cutaneous scarring and photo damage.

Fine needles puncture the skin, resulting in increased dermal elastin and collagen, collagen remodelling, and thickening of the epidermis and dermis. Additionally, skin needling creates small channels, which increase the absorption of topically applied preparations A property which has been used in various dermatological treatments.

Datoer

Sidst bekræftet:	01/31/2018
Først indsendt:	02/06/2018
Anslået tilmelding indsendt:	03/19/2018
Først indsendt:	03/20/2018
Sidste opdatering indsendt:	03/19/2018
Sidste opdatering indsendt:	03/20/2018
Faktisk startdato for undersøgelsen:	04/04/2018
Anslået primær afslutningsdato:	04/04/2019
Anslået afslutningsdato for undersøgelsen:	04/04/2020

Tilstand eller sygdom

Melasma

Intervention / behandling

Device: Microneedle

Fase

Armgrupper

Arm	Intervention / behandling
Active Comparator: A include 20 patients will be treated with TCA25% +microneedle 8 sessions for TCA 25 peel and 4 sessions for microneedle (derma pen).
Active Comparator: B include 20 patient will be treated with TCA 25% only ( 8 sessions)

Kriterier for støtteberettigelse

Alder berettiget til undersøgelse	18 Years Til 18 Years
Køn, der er berettiget til undersøgelse	All
Accepterer sunde frivillige	Ja
Kriterier	Inclusion Criteria: - Both sex will be included Age range from 18- 50 yrs.' old Patients with realistic expectations. Exclusion Criteria: - patients taking oral contraceptive pills. patients with history of polycystic ovary. pregnant and lactating females. patients with active infection. patients on isotretinoin. patients with history of keloids,or hypertrophic scars.

Resultat

Primære resultatforanstaltninger

1. Scoring of the patients according to modified melasma are abd severity index [mMASI] Scoring before and After last session will be done by 1 month [1 month after last session]

Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in [mMASI] score. Very good response:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in [mMASI] score at the end of the therapy. Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in [mMASI] score. Very goodresponse:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in [mMASI] score at the end of the therapy.

2. [mMASI] Scoring before and After last session will be done by 3 months [3 months after last session]

before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in [mMASI] score. Very good response:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no change in [mMASI] score at the end of the therapy. Efficacy of the treatment =(mMASIscorebefor -mMASIscoreafter)/mMASIscore before x100. Clinical efficacy was categorized into : Excellent response: if morethan 75%fall in [mMASI] score. Very goodresponse:if 50-75%fall in ]mMASI[score . Good respone: if 25-50%fall in ]mMASI[score. Poor response: if less25%fall in mMASIscore. No response: when there was no c

Microneedle and Trichloroaceticacid in Treatment of Melasma

Nøgleord

melasma

melanin

burns

melanosis

hyperpigmentation

tebusk

kamelia slægten

antimykotikum