Cryotherapy EffectNCT06491771
A Cryotherapy With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma
A study testing TargetCool in people with Cryotherapy Effect, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy Effect
- What is being tested?
- TargetCool
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Dermatology, Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
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
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.
Read the detailed description
TargetCool via boosting mode combined with tranexamic acid versus normal saline were studied in patients diagnosed with epidermal-typed melasma.
- Conditions
- Cryotherapy Effect
- Being tested
- TargetCool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TargetCoolDevice
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
| Study group | Role | What they receive |
|---|---|---|
| cryotherapy with tranexamic acid | Active comparator | precision cryotherapy via boosting mode combined with tranexamic acid Receives: Device: TargetCool |
| cryotherapy with normal saline | Placebo comparator | precision cryotherapy via boosting mode combined with normal saline Receives: Device: TargetCool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Secondary outcomes (5)
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)
Measured: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
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)
Measured: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
the changes in melanin index
Using Mexameter
Measured: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
the changes in erythema index
Using Mexameter
Measured: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Side effects
After treatment on both sides
Measured: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woraphong Manuskiatti, M.D., Mahidol University
- Investigators
- Woraphong Manuskiatti, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491771
- Sponsor's protocol ID
- Si 477/2024
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06491771
- Acronym / sponsor ID
- Si 477/2024
- Conditions
- Cryotherapy Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryotherapy with tranexamic acid | Active comparator | Device: TargetCoolprecision cryotherapy via boosting mode combined with tranexamic acid |
| cryotherapy with normal saline | Placebo comparator | Device: TargetCoolprecision cryotherapy via boosting mode combined with normal saline |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TargetCoolThe 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 | Device | cryotherapy with normal saline, cryotherapy with tranexamic acid |
Primary outcome
The change of Melasma Area and Severity Index score
Time frame: 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)
5 secondary outcomes
Physician improvement score
Time frame: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Overall improvement by patients
Time frame: 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
the changes in melanin index
Time frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
the changes in erythema index
Time frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Side effects
Time frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
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VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
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Acute Cryotherapy on Musculoskeletal Function and Biomarkers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woraphong Manuskiatti, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TargetCool in people with Cryotherapy Effect, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woraphong Manuskiatti, MD (6624194333, doctorlaser@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Melasma Area and Severity Index score (time frame: Baseline, 1, 2, 3 weeks after the first treatment and 1, 3 months after the last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.