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NCT Number: NCT06491771

A Cryotherapy 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.

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Key information

Conditions

Cryotherapy Effect

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TargetCool

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Supisara Wongdama, MD

CONTACT

[email protected]

66869898613

Woraphong Manuskiatti, MD

CONTACT

[email protected]

6624194333

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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