A Cryotherapy With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma

July 3, 2024 updated by: Woraphong Manuskiatti, M.D., Mahidol University

A Randomized Split-face Study of a Precision Cryotherapy Via Boosting Mode Combined With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma

This study aimed to evaluate the effectiveness of a precision cryotherapy via boosting mode combined with tranexamic acid versus normal saline in the treatment of melasma. Eighteen patients aged 25 to 60 years diagnosed with epidermal-typed melasma sized equal to or more than 2 cm on both cheeks were included. The patients were treated with a precision cryotherapy via boosting mode combined with tranexamic acid and normal saline on each side of cheek for 4 times every 1 week. Then, they were follow up at 1 and 3 months after the last treatment. Subjective assessment of physician and patient improvement were evaluated. Moreover, Melasma Area and Severity Index (MASI), melanin and erythema index using Mexameter were also recorded.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

TargetCool via boosting mode combined with tranexamic acid versus normal saline were studied in patients diagnosed with epidermal-typed melasma.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Department of Dermatology, Siriraj Hospital, Mahidol University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The patients diagnosed with epidermal-type melasma sized equal to or more than 2 cm on both sides of cheeks
  • Fitzpatrick skin type II-IV

Exclusion Criteria:

  • Pregnant or lactation
  • Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion
  • Subjects who have been treated with topical or oral treatment for melasma 6 months prior to the inclusion
  • Subjects who allergy to cryotherapy such as cryoglobulinemia, cold urticaria, and abnormal cold tolerance
  • Subjects with abnormal sensation such as diabetes mellitus
  • Active skin infections
  • History of hypertrophic scars or keloids History of hypertrophic scars or keloids

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cryotherapy with tranexamic acid
precision cryotherapy via boosting mode combined with tranexamic acid
Device: TargetCool
The patients were treated with TargetCool via boosting mode combined with tranexamic acid and normal saline on each side of cheek for 4 times every 1 week
Placebo Comparator: cryotherapy with normal saline
precision cryotherapy via boosting mode combined with normal saline
Device: TargetCool
The patients were treated with TargetCool via boosting mode combined with tranexamic acid and normal saline on each side of cheek for 4 times every 1 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of Melasma Area and Severity Index score
Time Frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Two blind dermatologists evaluated Melasma Area and Severity Index score on each side of cheek in every visits (0-48; best to worse)
Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician improvement score
Time Frame: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Using quartile scale (<0% = worsen; 0% = no change; 1-25% = mild improvement; 26-50% = moderate improvement; 51-75% = marked improvement; 76-100% = complete improvement)
1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Overall improvement by patients
Time Frame: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Using quartile scale (<0% = worsen; 0% = no change; 1-25% = mild improvement; 26-50% = moderate improvement; 51-75% = marked improvement; 76-100% = complete improvement)
1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
the changes in melanin index
Time Frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Using Mexameter
Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
the changes in erythema index
Time Frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Using Mexameter
Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Side effects
Time Frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
After treatment on both sides
Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Woraphong Manuskiatti, MD, Mahidol university

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 477/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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