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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.
TargetCool via boosting mode combined with tranexamic acid versus normal saline were studied in patients diagnosed with epidermal-typed melasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cryotherapy with tranexamic acid | Active Comparator | precision cryotherapy via boosting mode combined with tranexamic acid |
|
| cryotherapy with normal saline | Placebo Comparator | precision cryotherapy via boosting mode combined with normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TargetCool | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment |
| Overall improvement by patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Woraphong Manuskiatti, MD | Contact | 6624194333 | doctorlaser@gmail.com | |
| Supisara Wongdama, MD | Contact | 66869898613 | popsupdm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Woraphong Manuskiatti, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Siriraj Hospital, Mahidol University | Bangkok | 10700 | Thailand |
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Using quartile scale (<0% = worsen; 0% = no change; 1-25% = mild improvement; 26-50% = moderate improvement; 51-75% = marked improvement; 76-100% = complete improvement) |
| 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment |
| the changes in melanin index | Using Mexameter | Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment |
| the changes in erythema index | Using Mexameter | Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment |
| Side effects | After treatment on both sides | Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment |