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Different Dermatological Approaches the Treatment of Melasma

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ClinicalTrials.gov Identifier: NCT03923062
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Shimaa Hafez, Assiut University

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.

Condition or disease Intervention/treatment Phase
Melasma Device: chemicalpeeling Device: cryopeeling Combination Product: microneedling Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Different Dermatological Approaches in Treatment of Melasma: A Split Face Randomized Clinical Trial
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: G I A (right side): will be treated by chemical peeling
right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).
Device: chemicalpeeling

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.
Other Name: chemical peeling using Trichloroacetic acid 20%

Experimental: G I B(left side):will be treated by cryopeeling
left side of the patient's face will be treated by cryopeeling using Liquid Nitrogen.
Device: cryopeeling
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.
Other Name: cryopeeling using Liquid Nitrogen

Experimental: G II A (right side): will be treated by chemical peeling
right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).
Device: chemicalpeeling

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.
Other Name: chemical peeling using Trichloroacetic acid 20%

Experimental: G II B (left side):will be treated by tranexemic acid
left side of patient's face will be treated by tranexemic acid(cyclokapron)
Combination Product: microneedling

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
Other Name: microneedling using tranxemic acid




Primary Outcome Measures :
  1. melasma area and severity index (MASI) [ Time Frame: baseline ]

    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.

  2. photo of the patient [ Time Frame: baseline ]
    photo of the patient before and after treatment

  3. Biopsy [ Time Frame: baseline ]
    A punch biopsy will be taken from affected area for histipathological examination



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03923062


Contacts
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Contact: Shimaa Hafez, M.B.B.CH 01013881659 ext 0020 shimaahafez75@gmail.com
Contact: Doaa Samir, Ph.D 01143387171 ext 0020 doaasamir1@Yahoo.com

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Shimaa Hafez, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03923062    
Other Study ID Numbers: DDATM
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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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
Dermatologic Agents