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

January 23, 2018 updated by: Ereny Ramsis, Assiut University

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined peeling agents
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
Drug: Modified Jessner's solution
Modified Jessner's solution will be applied on the right side until frosting
Other Names:
  • Combined peel
Drug: Glycolic acid
Glycolic acid 70% on the other side of the face, then it will be neutralized with water after 5 minutes
Other Names:
  • Combined peel
Drug: Trichloroacetic acid
Trichloroacetic acid 20% will be applied in one uniform coat to both sides of the face until frosting
Other Names:
  • Combined peel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melasma Area and Severity Index (MASI)
Time Frame: The mean change from the baseline to week-12
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.
The mean change from the baseline to week-12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Photographs
Time Frame: change from the baseline to week-12
Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
change from the baseline to week-12
Global satisfaction score
Time Frame: change from the baseline to week-12
by Quartile rating scale
change from the baseline to week-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ereny Ramsis, Master, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2018

Primary Completion (Anticipated)

December 15, 2019

Study Completion (Anticipated)

December 15, 2020

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • combined peels

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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