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

NCT ID: NCT06491771

Last Updated: 2024-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-01

Brief Summary

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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

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

Conditions

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Cryotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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cryotherapy with tranexamic acid

precision cryotherapy via boosting mode combined with tranexamic acid

Group Type ACTIVE_COMPARATOR

TargetCool

Intervention Type 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

cryotherapy with normal saline

precision cryotherapy via boosting mode combined with normal saline

Group Type PLACEBO_COMPARATOR

TargetCool

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Woraphong Manuskiatti, M.D.

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Woraphong Manuskiatti, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Central Contacts

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Woraphong Manuskiatti, MD

Role: CONTACT

6624194333

Supisara Wongdama, MD

Role: CONTACT

66869898613

Other Identifiers

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Si 477/2024

Identifier Type: -

Identifier Source: org_study_id

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