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1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma

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ClinicalTrials.gov Identifier: NCT03008655
Recruitment Status : Unknown
Verified December 2016 by Huang Yu Chen, Taipei Medical University WanFang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Huang Yu Chen, Taipei Medical University WanFang Hospital

Brief Summary:

BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid both showed efficacy on the treatment of melasma. However, no combination therapy of both be reported.

OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection for melasma.


Condition or disease Intervention/treatment Phase
Melasma Procedure: intradermal tranexamic acid Device: Nd-YAG Not Applicable

Detailed Description:
METHODS: Twenty patients with melasma were included in a randomized controlled observer-blinded study with split-face design. Each side of the face was randomly allocated to either six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) or low influence 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection.Complication Improvement of melasma was assessed by Melasma area severity index (MASI),physician's global assessment (PhGA), MELASQOL scale, patient's global assessment (PGA), and patient's satisfaction at baseline,6th week,10th week after first treatment and 3 months, and 6 months after last treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Split-face Comparison of Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Vitamin C vs Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Intradermal Tranexamic Acid Injection for Melasma:a Single Blinded, Randomised Study
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nd-YAG
ND-YAG only
Device: Nd-YAG
six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz)

Experimental: Nd-YAG and intradermal tranexamic acid
Nd-YAG combine with intradermal tranexamic acid
Procedure: intradermal tranexamic acid
intradermal tranexamic acid injection

Device: Nd-YAG
six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz)




Primary Outcome Measures :
  1. Melasma area severity index (MASI) [ Time Frame: 6 months after last treatment ]

Secondary Outcome Measures :
  1. Quality of life by MELASQOL scale [ Time Frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment ]
  2. Improvement by patient's global assessment (PGA), [ Time Frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment ]
  3. Patient's satisfaction (VAS) [ Time Frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment ]
  4. Improvement by physician's global assessment (PhGA) [ Time Frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients > 20 years old with refractory melasma to topical treatment

Exclusion Criteria:

  • History of keloid, active eczema, active acne in the face, history of facial eczema, photosensitivity, use of isotretinoin in the past 6 months, pregnancy, and high exposure to sunlight or UV light (UVA or UVB)

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): NCT03008655


Contacts
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Contact: Yu Chen Huang, MD 886970746772 dhist2002@yahoo.com.tw

Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
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Principal Investigator: Yu Chen Huang, MD Taipei Medical University WanFang Hospital
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Responsible Party: Huang Yu Chen, Attending physician of Dermatology Department, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT03008655    
Other Study ID Numbers: N201610008
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants