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

Mahidol University

Status: Not yet enrolling

Conditions: Cryotherapy Effect

Treatments: Device: TargetCool

Study type: Interventional

Funder types: Other

Identifiers

NCT06491771

Si 477/2024

Details and patient eligibility

About

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.

Full description

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

Enrollment: 18 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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18 participants in 2 patient groups, including a placebo group

cryotherapy with tranexamic acid

Active Comparator group

Description:

precision cryotherapy via boosting mode combined with tranexamic acid

Treatment:

Device: TargetCool

cryotherapy with normal saline

Placebo Comparator group

Description:

precision cryotherapy via boosting mode combined with normal saline

Treatment:

Device: TargetCool