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Trial record 1 of 1 for:    Modified Jessner's Solution With Trichloroacetic Acid Versus Glycolic Acid With Trichloroacetic Acid
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Modified Jessner's Solution With Trichloroacetic Acid Versus Glycolic Acid With Trichloroacetic Acid

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ClinicalTrials.gov Identifier: NCT03153852
Recruitment Status : Not yet recruiting
First Posted : May 15, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ereny Ramsis, Assiut University

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 .

Condition or disease Intervention/treatment Phase
Melasma Drug: Modified Jessner's solution Drug: Glycolic acid Drug: Trichloroacetic acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 15, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Combined peel

Drug: Trichloroacetic acid
Trichloroacetic acid 20% will be applied in one uniform coat to both sides of the face until frosting
Other Name: Combined peel




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Global satisfaction score [ Time Frame: change from the baseline to week-12 ]
    by Quartile rating scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153852


Contacts
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Contact: Ensaf Abdel-Maguid, MD 01005263721 amiraali21@yahoo.com
Contact: Amira Ali, MD 01005263721 amiraali21@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Ereny Ramsis, Master Assiut University
Publications:

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Responsible Party: Ereny Ramsis, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03153852    
Other Study ID Numbers: combined peels
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Glycolic acid
Keratolytic Agents
Dermatologic Agents