Cryotherapy Effect
Conditions
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.
Interventions
DEVICETargetCool
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
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 melanin index | Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment | Using Mexameter |
| the changes in erythema 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 |
Countries
Thailand
Contacts
Primary ContactWoraphong Manuskiatti, MD
Backup ContactSupisara Wongdama, MD
Outcome results
None listed