A Cryotherapy With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma (NCT06491771) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Cryotherapy With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma
Thailand18 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
25 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change of Melasma Area and Severity Index score
Timeframe: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment