A Cryotherapy With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma
ConditionCryotherapy Effect
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-60
SponsorMahidol University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TargetCool
DeviceThe 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
Treatment groups
18 Participants
are divided into 2 treatment groupsGroup A: cryotherapy with tranexamic acidActive comparator 1 intervention
Group B: cryotherapy with normal salinePlacebo comparator 1 intervention
Trial outcomes
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)
Time frame
Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatmentSecondary outcomes
1
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 treatment2
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 treatment3
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 treatment4
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 treatmentSponsors and contacts
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Source ClinicalTrials.gov
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