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Modified Jessner's Solution With Trichloroacetic Acid Versus Glycolic Acid With Trichloroacetic Acid

Primary Purpose

Melasma

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Modified Jessner's solution
Glycolic acid
Trichloroacetic acid
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 - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults >18 years old.
  2. Clinical diagnosis of melasma.
  3. Mental capacity to give informed consent.

Exclusion Criteria:

  1. Pregnant females and females on oral contraceptive pills.
  2. Patients with a history of hypertrophic scars or keloids.
  3. Patients with recurrent herpes infection.
  4. Patients with unrealistic expectation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Combined peeling agents

    Arm Description

    Modified Jessner's solution will be applied on the right side and glycolic acid 70% on the other side of the face.trichloroacetic acid 20% will be applied in one uniform coat to both sides

    Outcomes

    Primary Outcome Measures

    Melasma Area and Severity Index (MASI)
    MASI = .3A(D+H) [forhead] + .3A(D+H)[right malar] + .3A(D+H)[left malar] + .1A(D+H)[chin]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.

    Secondary Outcome Measures

    Evaluation of Photographs
    Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
    Global satisfaction score
    by Quartile rating scale

    Full Information

    First Posted
    May 11, 2017
    Last Updated
    January 23, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03153852
    Brief Title
    Modified Jessner's Solution With Trichloroacetic Acid Versus Glycolic Acid With Trichloroacetic Acid
    Official Title
    The Efficacy of Combined Peels in Treatment of Melasma Using Modified Jessner's Solution With 20%Trichloroacetic Acid Versus 70%Glycolic Acid With 20% Trichloroacetic Acid : A Split-face Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2018 (Anticipated)
    Primary Completion Date
    December 15, 2019 (Anticipated)
    Study Completion Date
    December 15, 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 a common acquired disorder of hyperpigmentation characterized by irregular light brown to dark brown patches of hyperpigmentation commonly affecting the face. The trunk and arms are also occasionally involved .
    Detailed Description
    Key etiologic factors include a genetic predisposition, solar damage, barrier abnormalities, and unique sensitivities to hormonal changes including pregnancy, oral contraceptives, and hormone replacement therapy .Melasma can be divided into centrofacial, malar, and mandibular, according to the pigment distribution on the skin. The hyperpigmented patches are usually symmetrical and have a sharp irregular border.On wood's light examination three forms of melasma exist (epidermal, dermal, and mixed). Epidermal & mixed types shows accentuation of pigmentation, while there is no change in dermal type The epidermal type is the most responsive to treatment .Melasma is often difficult to treat, and the condition may be refractory. Principles of therapy include protection from ultraviolet light, inhibition of melanocyte activity and melanin synthesis, and the disruption and removal of melanin granules .Many depigmenting agents and other therapies such as chemical peeling are used for treating melasma, in the form of monotherapy or combined therapy .The most commonly used peeling agents are alpha-hydroxy-acids, glycolic acid , Jessner solution, salicylic acid resorcinol,trichloroacetic acid , pyruvic acid and phenol Several hypopigmenting agents such as topical hydroquinone (2 to 4%) alone or in combination with tretinoin (0.05 to 0.1%) have been used with differing results. Topical azelaic acid (15 to 20%) can be as efficacious as hydroquinone. Kojic acid, alone or in combination with glycolic acid or hydroquinone, has shown good results, due to its inhibitory action on tyrosinase. Chemical peeling is apromising treatment for numerous pigmentary disorders as melasma.Which aim to remove the melanin ,rather than the inhibition of melanocytes or melanogenesis by causing controlled necrosis and subsequent regeneration of the epidermis ,apart from remodeling of collagen and elastic fiberes in the dermis . The gold standard for chemical peeling agents is trichloroacetic acid It is a traditional chemical substance which has been used for both superficial and medium-depth as well as deep peelings.It is not expensive, stable, not light-sensitive and does not need to be neutralized .Classic Jessner's solution is a combination of different chemical substances, including salicylic acid(14gm), resorcinol(14gm), lactic acid(14gm) and ethanol, which can be used either alone for superficial peeling or in combination with other agents to make easier medium-depth procedures. Dr.Max Jessner originally formulated this peel to reduce the concentration and toxicity of each of the individual ingredients while increasing efficacy. Modified formula: lactic acid(17%), salicylic acid(17%), citric acid(8%) and ethanol .It is preferred , to avoid possible allergic reactions and hyperpigmentation problems, which may be created by resorcinol, especially in skin types V and VI.Gary Monheit has popularized the combination peel using the classic Jessner's solution combined with trichloroacetic acid , to achieve a more uniform penetration and an excellent peel with a low, safe concentration of trichloroacetic acid Glycolic acid it is one of the most frequently used superficial peeling agent. It is stable , not light sensitive, inexpensive and easy to administer. Generally it is safe; scarring uncommon; persistent erythema and postpeel hyperpigmentation rarely seen.The depth of a Glycolic acid peel is a function of the concentration,volume and duration of application.Glycolic acid has been used in combination with trichloroacetic acid peels .70% glycolic acid is applied to the skin for 2 minutes.This is then neutralized,followed by the application of 35% trichloroacetic acid peels without any prior acetone scrub.This combination is thought to produce greater neoelastogenesis and less inflammation than Jessner/trichloroacetic acid combination.

    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
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Combined peeling agents
    Arm Type
    Experimental
    Arm Description
    Modified Jessner's solution will be applied on the right side and glycolic acid 70% on the other side of the face.trichloroacetic acid 20% will be applied in one uniform coat to both sides
    Intervention Type
    Drug
    Intervention Name(s)
    Modified Jessner's solution
    Other Intervention Name(s)
    Combined peel
    Intervention Description
    Modified Jessner's solution will be applied on the right side until frosting
    Intervention Type
    Drug
    Intervention Name(s)
    Glycolic acid
    Other Intervention Name(s)
    Combined peel
    Intervention Description
    Glycolic acid 70% on the other side of the face, then it will be neutralized with water after 5 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    Trichloroacetic acid
    Other Intervention Name(s)
    Combined peel
    Intervention Description
    Trichloroacetic acid 20% will be applied in one uniform coat to both sides of the face until frosting
    Primary Outcome Measure Information:
    Title
    Melasma Area and Severity Index (MASI)
    Description
    MASI = .3A(D+H) [forhead] + .3A(D+H)[right malar] + .3A(D+H)[left malar] + .1A(D+H)[chin]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.
    Time Frame
    The mean change from the baseline to week-12
    Secondary Outcome Measure Information:
    Title
    Evaluation of Photographs
    Description
    Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
    Time Frame
    change from the baseline to week-12
    Title
    Global satisfaction score
    Description
    by Quartile rating scale
    Time Frame
    change from the baseline to week-12

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults >18 years old. Clinical diagnosis of melasma. Mental capacity to give informed consent. Exclusion Criteria: Pregnant females and females on oral contraceptive pills. Patients with a history of hypertrophic scars or keloids. Patients with recurrent herpes infection. Patients with unrealistic expectation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ensaf Abdel-Maguid, MD
    Phone
    01005263721
    Email
    amiraali21@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amira Ali, MD
    Phone
    01005263721
    Email
    amiraali21@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ereny Ramsis, Master
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26538717
    Citation
    Yalamanchili R, Shastry V, Betkerur J. Clinico-epidemiological Study and Quality of Life Assessment in Melasma. Indian J Dermatol. 2015 Sep-Oct;60(5):519. doi: 10.4103/0019-5154.164415.
    Results Reference
    background
    PubMed Identifier
    15916218
    Citation
    Perez MI. The stepwise approach to the treatment of melasma. Cutis. 2005 Apr;75(4):217-22.
    Results Reference
    background
    PubMed Identifier
    11555002
    Citation
    Javaheri SM, Handa S, Kaur I, Kumar B. Safety and efficacy of glycolic acid facial peel in Indian women with melasma. Int J Dermatol. 2001 May;40(5):354-7. doi: 10.1046/j.1365-4362.2001.01149.x.
    Results Reference
    background
    PubMed Identifier
    24679999
    Citation
    Molinar VE, Taylor SC, Pandya AG. What's new in objective assessment and treatment of facial hyperpigmentation? Dermatol Clin. 2014 Apr;32(2):123-35. doi: 10.1016/j.det.2013.12.008.
    Results Reference
    background
    PubMed Identifier
    17097400
    Citation
    Gupta AK, Gover MD, Nouri K, Taylor S. The treatment of melasma: a review of clinical trials. J Am Acad Dermatol. 2006 Dec;55(6):1048-65. doi: 10.1016/j.jaad.2006.02.009. Epub 2006 Sep 28.
    Results Reference
    background
    PubMed Identifier
    16631968
    Citation
    Rendon M, Berneburg M, Arellano I, Picardo M. Treatment of melasma. J Am Acad Dermatol. 2006 May;54(5 Suppl 2):S272-81. doi: 10.1016/j.jaad.2005.12.039.
    Results Reference
    background
    PubMed Identifier
    18472062
    Citation
    Clark E, Scerri L. Superficial and medium-depth chemical peels. Clin Dermatol. 2008 Mar-Apr;26(2):209-18. doi: 10.1016/j.clindermatol.2007.09.015.
    Results Reference
    background
    PubMed Identifier
    11702317
    Citation
    Perez-Bernal A, Munoz-Perez MA, Camacho F. Management of facial hyperpigmentation. Am J Clin Dermatol. 2000 Sep-Oct;1(5):261-8. doi: 10.2165/00128071-200001050-00001.
    Results Reference
    background
    PubMed Identifier
    18472061
    Citation
    Landau M. Chemical peels. Clin Dermatol. 2008 Mar-Apr;26(2):200-8. doi: 10.1016/j.clindermatol.2007.09.012.
    Results Reference
    background
    PubMed Identifier
    18688104
    Citation
    Khunger N; IADVL Task Force. Standard guidelines of care for chemical peels. Indian J Dermatol Venereol Leprol. 2008 Jan;74 Suppl:S5-12.
    Results Reference
    background
    PubMed Identifier
    2778184
    Citation
    Monheit GD. The Jessner's + TCA peel: a medium-depth chemical peel. J Dermatol Surg Oncol. 1989 Sep;15(9):945-50. doi: 10.1111/j.1524-4725.1989.tb03181.x.
    Results Reference
    background
    PubMed Identifier
    14749844
    Citation
    Monheit GD. Chemical peels. Skin Therapy Lett. 2004 Feb;9(2):6-11.
    Results Reference
    background
    PubMed Identifier
    17524124
    Citation
    Soliman MM, Ramadan SA, Bassiouny DA, Abdelmalek M. Combined trichloroacetic acid peel and topical ascorbic acid versus trichloroacetic acid peel alone in the treatment of melasma: a comparative study. J Cosmet Dermatol. 2007 Jun;6(2):89-94. doi: 10.1111/j.1473-2165.2007.00302.x.
    Results Reference
    background
    PubMed Identifier
    7492140
    Citation
    Grimes PE. Melasma. Etiologic and therapeutic considerations. Arch Dermatol. 1995 Dec;131(12):1453-7. doi: 10.1001/archderm.131.12.1453.
    Results Reference
    background

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