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

Not Applicable

Not yet recruiting

• Conditions: Cryotherapy Effect

• Registration Number: NCT06491771
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-06-25
• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-02-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The change of Melasma Area and Severity Index score	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 Outcome Measures

Name	Time	Method
Physician improvement score	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)
the changes in melanin index	Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment	Using Mexameter
Side effects	Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment	After treatment on both sides
Overall improvement by patients	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)
the changes in erythema index	Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment	Using Mexameter

Trial Locations

Locations (1)

Department of Dermatology, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand