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

N/ANot Yet RecruitingNCT06491771

Mahidol University18 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cryotherapy Effect

Interventions

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The change of Melasma Area and Severity Index score

Two blind dermatologists evaluated Melasma Area and Severity Index score on each side of cheek in every visits (0-48; best to worse)

Time frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment

Secondary Outcomes

Physician improvement score

Using quartile scale (\<0% = worsen; 0% = no change; 1-25% = mild improvement; 26-50% = moderate improvement; 51-75% = marked improvement; 76-100% = complete improvement)

Time frame: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment

Overall improvement by patients

Using quartile scale (\<0% = worsen; 0% = no change; 1-25% = mild improvement; 26-50% = moderate improvement; 51-75% = marked improvement; 76-100% = complete improvement)

Time frame: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment

the changes in melanin index

Using Mexameter

Time frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment

the changes in erythema index

Using Mexameter

Time frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment

Side effects

After treatment on both sides

Time frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts