Different Dermatological Approaches the Treatment of Melasma
Primary Purpose
Melasma
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
chemicalpeeling
cryopeeling
microneedling
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
Eligibility Criteria
Inclusion Criteria:
- -Subjects presented with melasma.
- Age 20-40 years old.
- Melasma persisting for more than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents.
Exclusion Criteria:
- -History of photosensitivity, keloids, hypertrophic scarring and post- inflammatory hyperpigmentation.
- Pregnancy and lactation.
- Subjects with local inflammatory skin disorder or active herpes infection at the site of procedure.
- Subjects with history of medical diseases which contraindicate cryosurgery such as; cold intolerance, cold urticaria, Raynaud's disease and history of allergic reactions to cryosurgery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
G I A (right side): will be treated by chemical peeling
G I B(left side):will be treated by cryopeeling
G II A (right side): will be treated by chemical peeling
G II B (left side):will be treated by tranexemic acid
Arm Description
right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).
left side of the patient's face will be treated by cryopeeling using Liquid Nitrogen.
right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).
left side of patient's face will be treated by tranexemic acid(cyclokapron)
Outcomes
Primary Outcome Measures
melasma area and severity index (MASI)
Clinical evaluation of melasma severity will be done by melasma area severity index (MASI) every session and at the end of treatment.
No response, no improvement.
Mild response, <25% improvement.
Moderate response, 25% to < 50% improvement.
Good response, 50% to < 75% improvement.
Very good response, >75% improvement.
photo of the patient
photo of the patient before and after treatment
Biopsy
A punch biopsy will be taken from affected area for histipathological examination
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03923062
Brief Title
Different Dermatological Approaches the Treatment of Melasma
Official Title
Different Dermatological Approaches in Treatment of Melasma: A Split Face Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
December 1, 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacy and safety of cryopeeling (using Liquid Nitrogen) and tranexemic acid (cyclokapron) versus chemical peeling (using TCA 20%) in treatment of melasma.
Detailed Description
Melasma is a common, acquired, circumscribed hypermelanosis of the sun-exposed skin, It presents as symmetric, hyperpigmented macules having irregular, serrated, and geographic borders , The most common locations are the cheeks, upper lips, the chin and the forehead, but other sun-exposed areas may also be occasionally involved .
Studies has indicated the role of several risk factors such as genetics, sunlight, age, gender, hormones, pregnancy, thyroid dysfunction, cosmetics and medications .
Histologic features of melasma include an increase in the content of both epidermal and dermal melanin, but the quantity varies with the intensity of hyperpigmentation. In addition, most studies show no quantitative increase in melanocytes; however, the cells are enlarged with prominent and elongated dendrites and more abundant melanosomes. Additional features of the involved skin include solar elastosis and increased mast cells, dermal blood vessels, and expression of vascular endothelial growth factor.
Commonly used topical agents for the treatment of melasma include hydroquinone, azelaic acid, kojic acid, glycolic acid, salicylic acid and tretinoin. Of these treatments, hydroquinone remains the gold standard .Second-line treatments, such as chemical peels and lasers, are efficacious in some patients .
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 regeneration of new epidermal and dermal tissues [khunger, 2008]. The mechanism of action in melasma is the removal of unwanted melanin via controlled chemical burn of the skin .
Trichloroacetic acid has been used as a peeling agent for a long time and is still the most effective and safest agent for medium peeling, Its depth of penetration depends on the TCA concentration and on the preparation of the skin, specially the degreasing. Between 10% and 30% concentration is considered a superficial peel; above 30% provides a medium-depth peel.
Cryopeeling is a technique that uses cryotherapy in a diffuse manner throughout the skin region affected by sun damage in order to promote cell renewal and desquamation, with possible benefits in the appearance of new lesions caused by photodamage. Up to the investigator's knowledge, few studies were performed evaluating such technique.
Recently, trans-4-(Aminomethyl) cyclohexanecarboxylic acid, or tranexamic acid (TA), has been proposed as a new treatment for melasma.The main mechanism of the hypopigmentant effects of TA is due to its antiplasmin activity .In addition, TA is similar to tyrosine in a portion of its structure, which can inhibit tyrosinase competitively .Also, Plasmin transforms the vascular endothelial growth factor (VEGF) into a diffusing form, and histological examination showed that TA plays an important role in the reduction of erythema and vascularities and the number of mast cell in the dermis.Various forms of TA are used orally, topically and as a microinjection for the treatment of melasma.
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
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
G I A (right side): will be treated by chemical peeling
Arm Type
Experimental
Arm Description
right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).
Arm Title
G I B(left side):will be treated by cryopeeling
Arm Type
Experimental
Arm Description
left side of the patient's face will be treated by cryopeeling using Liquid Nitrogen.
Arm Title
G II A (right side): will be treated by chemical peeling
Arm Type
Experimental
Arm Description
right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).
Arm Title
G II B (left side):will be treated by tranexemic acid
Arm Type
Experimental
Arm Description
left side of patient's face will be treated by tranexemic acid(cyclokapron)
Intervention Type
Device
Intervention Name(s)
chemicalpeeling
Other Intervention Name(s)
chemical peeling using Trichloroacetic acid 20%
Intervention Description
Cleansing and degreasing the face with alcohol .
The patients must be sitting at an angle of 45.
A 2 × 2 cm cotton gauze will be used to apply TCA 20%.
We will apply the acid from the midline to the right side of the forehead and under the right eye, covering the right cheek and perioral area.
We then will wait for a few minutes and will observe the frost developing.
The patient will be then allowed to wash her face.
Intervention Type
Device
Intervention Name(s)
cryopeeling
Other Intervention Name(s)
cryopeeling using Liquid Nitrogen
Intervention Description
Cryopeeling will be performed by spraying the freezing substance(Liquid Nitrogen) on the face at 1-2cm distance and moving along the affected area until freezing appear.
Intervention Type
Combination Product
Intervention Name(s)
microneedling
Other Intervention Name(s)
microneedling using tranxemic acid
Intervention Description
Tranexamic acid will be used in aconcentration of 4mg/ml ,1ml will be used fo half of the face.
After gentle cleansing, topical analgesic cream will be applied over the area to be treated.
The microneedles will be used, the skin will be stretched and microneedling will be carried out in vertical, horizontal, and both diagonal directions for about four to five times. Tranexamic acid, 0.5 to 1 ml (4 mg/mL), will be applied over this area, and the procedure will be repeated four to five times in the above-said directions
Primary Outcome Measure Information:
Title
melasma area and severity index (MASI)
Description
Clinical evaluation of melasma severity will be done by melasma area severity index (MASI) every session and at the end of treatment.
No response, no improvement.
Mild response, <25% improvement.
Moderate response, 25% to < 50% improvement.
Good response, 50% to < 75% improvement.
Very good response, >75% improvement.
Time Frame
baseline
Title
photo of the patient
Description
photo of the patient before and after treatment
Time Frame
baseline
Title
Biopsy
Description
A punch biopsy will be taken from affected area for histipathological examination
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Subjects presented with melasma.
Age 20-40 years old.
Melasma persisting for more than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents.
Exclusion Criteria:
-History of photosensitivity, keloids, hypertrophic scarring and post- inflammatory hyperpigmentation.
Pregnancy and lactation.
Subjects with local inflammatory skin disorder or active herpes infection at the site of procedure.
Subjects with history of medical diseases which contraindicate cryosurgery such as; cold intolerance, cold urticaria, Raynaud's disease and history of allergic reactions to cryosurgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shimaa Hafez, M.B.B.CH
Phone
01013881659
Ext
0020
Email
shimaahafez75@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa Samir, Ph.D
Phone
01143387171
Ext
0020
Email
doaasamir1@Yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
17363223
Citation
Kim EH, Kim YC, Lee ES, Kang HY. The vascular characteristics of melasma. J Dermatol Sci. 2007 May;46(2):111-6. doi: 10.1016/j.jdermsci.2007.01.009. Epub 2007 Mar 23.
Results Reference
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PubMed Identifier
18631207
Citation
Hexsel D, Rodrigues TC, Dal'Forno T, Zechmeister-Prado D, Lima MM. Melasma and pregnancy in southern Brazil. J Eur Acad Dermatol Venereol. 2009 Mar;23(3):367-8. doi: 10.1111/j.1468-3083.2008.02885.x. Epub 2008 Jul 7. No abstract available.
Results Reference
background
PubMed Identifier
21920241
Citation
Sheth VM, Pandya AG. Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-697. doi: 10.1016/j.jaad.2010.12.046.
Results Reference
background
PubMed Identifier
16533230
Citation
Moin A, Jabery Z, Fallah N. Prevalence and awareness of melasma during pregnancy. Int J Dermatol. 2006 Mar;45(3):285-8. doi: 10.1111/j.1365-4632.2004.02470.x.
Results Reference
background
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
PubMed Identifier
23378706
Citation
Sarkar R, Bansal S, Garg VK. Chemical peels for melasma in dark-skinned patients. J Cutan Aesthet Surg. 2012 Oct;5(4):247-53. doi: 10.4103/0974-2077.104912.
Results Reference
background
PubMed Identifier
11457690
Citation
Monheit GD, Chastain MA. Chemical peels. Facial Plast Surg Clin North Am. 2001 May;9(2):239-55, viii.
Results Reference
background
PubMed Identifier
28283893
Citation
Perper M, Eber AE, Fayne R, Verne SH, Magno RJ, Cervantes J, ALharbi M, ALOmair I, Alfuraih A, Nouri K. Tranexamic Acid in the Treatment of Melasma: A Review of the Literature. Am J Clin Dermatol. 2017 Jun;18(3):373-381. doi: 10.1007/s40257-017-0263-3.
Results Reference
background
PubMed Identifier
22329442
Citation
Na JI, Choi SY, Yang SH, Choi HR, Kang HY, Park KC. Effect of tranexamic acid on melasma: a clinical trial with histological evaluation. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1035-9. doi: 10.1111/j.1468-3083.2012.04464.x. Epub 2012 Feb 13.
Results Reference
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PubMed Identifier
26955108
Citation
Sharma YK, Gupta A. Some Other Serendipitous Discoveries in Dermatology. Indian J Dermatol. 2016 Jan-Feb;61(1):95-6. doi: 10.4103/0019-5154.174045. No abstract available.
Results Reference
background
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Different Dermatological Approaches the Treatment of Melasma
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