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
About this trial
This is an interventional treatment trial for Melasma
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.
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
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
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Modified Jessner's Solution With Trichloroacetic Acid Versus Glycolic Acid With Trichloroacetic Acid
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