Clinical trial NCT06491771: A Cryotherapy With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma
Official title: A Randomized Split-face Study of a Precision Cryotherapy Via Boosting Mode Combined With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cryotherapy Effect
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Physician improvement score
timeFrame: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
measure: Overall improvement by patients
timeFrame: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
measure: the changes in melanin index
timeFrame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
measure: the changes in erythema index
timeFrame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
measure: Side effects
timeFrame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Woraphong Manuskiatti, MD
role: PRINCIPAL_INVESTIGATOR
References: