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Microneedle and Trichloroaceticacid in Treatment of Melasma

Primary Purpose

Melasma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microneedle
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    A

    B

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    [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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2018
    Last Updated
    March 20, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03472235
    Brief Title
    Microneedle and Trichloroaceticacid in Treatment of Melasma
    Official Title
    Combined Trichlotoaceticacid and Microneedle Versus Trichlroacetic Acid Alone in the Treatment of Melasma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 5, 2018 (Anticipated)
    Primary Completion Date
    April 5, 2019 (Anticipated)
    Study Completion Date
    April 5, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melasma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Description
    include 20 patients will be treated with TCA25% +microneedle 8 sessions for TCA 25 peel and 4 sessions for microneedle (derma pen).
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    include 20 patient will be treated with TCA 25% only ( 8 sessions)
    Intervention Type
    Device
    Intervention Name(s)
    Microneedle
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    1 month after last session
    Title
    [mMASI] Scoring before and After last session will be done by 3 months
    Description
    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
    Time Frame
    3 months after last session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21920242
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Microneedle and Trichloroaceticacid in Treatment of Melasma

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