Microneedle and Trichloroaceticacid in Treatment of Melasma

NCT03472235 | Unknown

• 1 other identifier: MTTM
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  1 month after last session

• [mMASI] Scoring before and After last session will be done by 3 months

  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

  3 months after last session

Study Arms (2)

A

ACTIVE COMPARATOR

include 20 patients will be treated with TCA25% +microneedle 8 sessions for TCA 25 peel and 4 sessions for microneedle (derma pen).

Device: Microneedle

B

ACTIVE COMPARATOR

include 20 patient will be treated with TCA 25% only ( 8 sessions)

Device: Microneedle

Interventions

Microneedle DEVICE

TCA peeling session: Facial skin will be cleansed with tap water and degreased by rubbing with an alcohol sponge . Then TCA 25% will be applied to the whole face by cotton tipped applicator or gauze pad. The entire face will be treated until complete frosting occur. The patients will be instructed to wash their faces to decrease the burning sensation. Combined session: starts with microneedle using microneedle device (Derma pen) The skin of each patient is cleaned with anti septic solution and anesthetic cream may be applied to lessen discomfort. (Dermapen) will be applied on the lesional skin in four direction, vertical, horizontal and in the two diagonal until pin point bleeding occur which will be gently massaged . After 10 minutes TCA peeling will be applied TCA peeling will be done for 8 session with 2 weeks interval between each session. Microneedle will be done for 4session with 4 weeks interval between each session.

A; B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both sex will be included Age range from 18- 50 yrs.' old Patients with realistic expectations.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Sheth VM, Pandya AG. Melasma: a comprehensive update: part II. J Am Acad Dermatol. 2011 Oct;65(4):699-714. doi: 10.1016/j.jaad.2011.06.001.

  PMID: 21920242 BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: TCA peeling session: Facial skin will be cleansed with tap water and degreased by rubbing with an alcohol sponge . Then TCA 25% will be applied to the whole face by cotton tipped applicator or gauze pad. The entire face will be treated until complete frosting occur. The patients will be instructed to wash their faces to decrease the burning sensation. Combined session: starts with microneedling using microneedling device (Dermapen) The skin of each patient is cleaned with anti septic solution and anesthetic cream may be applied to lessen discomfort. (Dermapen) will be applied on the lesional skin in four direction, vertical, horizontal and in the two diagonal until pin point bleeding occur which will be gently massaged . After 10 minutes TCA peeling will be applied TCA peeling will be done for 8 session with 2 weeks interval between each session. Microneedling will be done for 4session with 4 weeks interval between each session.

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: March 21, 2018
• Study Start: April 5, 2018
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2020
• Last Updated: March 21, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share