NCT06491771

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

June 25, 2024

Last Update Submit

July 3, 2024

Conditions

Cryotherapy Effect

Outcome Measures

Primary Outcomes (1)

  • 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)

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

Secondary Outcomes (5)

  • Physician improvement score

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

  • Overall improvement by patients

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

  • the changes in melanin index

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

  • the changes in erythema index

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

  • Side effects

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

Study Arms (2)

cryotherapy with tranexamic acid

ACTIVE COMPARATOR

precision cryotherapy via boosting mode combined with tranexamic acid

Device: TargetCool

cryotherapy with normal saline

PLACEBO COMPARATOR

precision cryotherapy via boosting mode combined with normal saline

Device: TargetCool

Interventions

TargetCoolDEVICE

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 salinecryotherapy with tranexamic acid

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactation
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Study Officials

  • Woraphong Manuskiatti, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Woraphong Manuskiatti, MD

CONTACT

6624194333doctorlaser@gmail.com

Supisara Wongdama, MD

CONTACT

66869898613popsupdm@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 9, 2024

Study Start

July 1, 2024

Primary Completion

February 1, 2025

Study Completion

July 1, 2025

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)