Focus on Laser Treatment of Nevus of Ota in Thai PatientsNCT04481178
A Retrospective Study on Laser Treatment of Nevus of Ota in Thai Patients
An observational study of Focus on Laser Treatment of Nevus of Ota in Thai Patients, run by Mahidol University at 1 site in Thailand.
Trial summary
A retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Focus on Laser Treatment of Nevus of Ota in Thai Patients
- What is being tested?
- Laser (QS, Picosecond laser)
- How many people
- 79 participants
- Where
- 1 siteThailand
- Study dates
- 15 Sep 2020to 1 Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with Nevus of Ota
Who may be able to join
- Patient with Nevus of Ota
- Complete data between January 2008 - December 2018
Who cannot join
- Incomplete data
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Woraphong Manuskiatti, M.D., 662-419-4333, siwmn@mahidol.ac.th
Rungsima Wanitphakdeedecha, M.D., 662-419-9922, sirwn@mahidol.ac.th
About this study
A retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients
Read the detailed description
Nevus of Ota is a benign dermal melanocytic nevus found most commonly in Asians. About 50-60% of all cases have the age of onset at birth or within the first year of life, others appear before puberty. It typically presents as a unilateral mottled blue-gray macules and patches distributed along the first and second branches of trigeminal nerve. Due to its marked hyperpigmentation on the face which does not resolved spontaneously, patients may experience psychosocial disturbances and often seek for treatments. Based on selective photothermolysis theory, Q-switched lasers (ruby 694nm, alexandrite 755nm, Nd:YAG 1064nm) have been used for the treatment of nevus of Ota with a success rate of 95% after 6-8 sessions. Reported complications from the lasers are hypopigmentation(15.3%), hyperpigmentation(2.9%), texture changes (2.9%), and scarring (1.9%). Siriraj Skin Laser Center provides laser treatment for nevus of Ota using mainly Q-switched Nd:YAG laser and Picosecond laser. The study of efficacy and complications of Q-switched Nd:YAG and Picosecond laser in the treatment of Nevus of Ota in Thai patients has never been reported. Therefore, we conduct a retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients.
- Being tested
- Laser (QS, Picosecond laser)
- Keywords
- Nevus of Ota, laser treatment, Thai
- Medical subject headings
- Nevus of Ota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser (QS, Picosecond laser)Other
QS-Nd Yag Laser, Picosecond laser
| Study group | Role | What they receive |
|---|---|---|
| patients with nevus of Ota | patients with nevus of Ota who had been treated with laser at Siriraj hospital Receives: Other: Laser (QS, Picosecond laser) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of laser treatment in paitients with Nevus of Ota
Fading of lesions after treatment by chart review
Measured: 2008-2018
Secondary outcomes (2)
Complication of laser such as hyperpigmentation, hypopigmentation, and scars
Complication of laser such as hyperpigmentation, hypopigmentation, and scars
Measured: 2008-2018
Relapse rate after laser treatment
rate of recurrence after treatment
Measured: 2008-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start15 Sep 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus on Laser Treatment of Nevus of Ota in Thai PatientsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 79 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481178
- Sponsor's protocol ID
- si347/2020
- Status last verified
- Sep 2020
- First submitted
- 18 Jul 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Achavanuntakul P, Manuskiatti W, Wanitphakdeedecha R, Jantarakolica T. Early Treatment Initiation Improves Outcomes in Nevus of Ota: A 10-Year Retrospective Study. Am J Clin Dermatol. 2022 Jan;23(1):105-114. doi: 10.1007/s40257-021-00637-0. Epub 2021 Oct 24.
PubMed 34693508
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Laser Treatment of Nevus of Ota in Thai Patients
- ClinicalTrials.gov ID
- NCT04481178
- Acronym / sponsor ID
- si347/2020
- Keywords
- Nevus of Ota, laser treatment, Thai
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 22 Jul 2020 (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.
A retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients
Detailed description
Nevus of Ota is a benign dermal melanocytic nevus found most commonly in Asians. About 50-60% of all cases have the age of onset at birth or within the first year of life, others appear before puberty. It typically presents as a unilateral mottled blue-gray macules and patches distributed along the first and second branches of trigeminal nerve. Due to its marked hyperpigmentation on the face which does not resolved spontaneously, patients may experience psychosocial disturbances and often seek for treatments. Based on selective photothermolysis theory, Q-switched lasers (ruby 694nm, alexandrite 755nm, Nd:YAG 1064nm) have been used for the treatment of nevus of Ota with a success rate of 95% after 6-8 sessions. Reported complications from the lasers are hypopigmentation(15.3%), hyperpigmentation(2.9%), texture changes (2.9%), and scarring (1.9%). Siriraj Skin Laser Center provides laser treatment for nevus of Ota using mainly Q-switched Nd:YAG laser and Picosecond laser. The study of efficacy and complications of Q-switched Nd:YAG and Picosecond laser in the treatment of Nevus of Ota in Thai patients has never been reported. Therefore, we conduct a retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with nevus of Ota | – | Other: Laser (QS, Picosecond laser)patients with nevus of Ota who had been treated with laser at Siriraj hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with Nevus of Ota
Key inclusion criteria (2 listed)
- Patient with Nevus of Ota
- Complete data between January 2008 - December 2018
Key exclusion criteria (1 listed)
- Incomplete data
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 |
|---|---|---|
| Laser (QS, Picosecond laser)QS-Nd Yag Laser, Picosecond laser | Other | patients with nevus of Ota |
Primary outcome
Efficacy of laser treatment in paitients with Nevus of Ota
Time frame: 2008-2018
Fading of lesions after treatment by chart review
2 secondary outcomes
Complication of laser such as hyperpigmentation, hypopigmentation, and scars
Time frame: 2008-2018
Relapse rate after laser treatment
Time frame: 2008-2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 34693508Achavanuntakul P, Manuskiatti W, Wanitphakdeedecha R, Jantarakolica T. Early Treatment Initiation Improves Outcomes in Nevus of Ota: A 10-Year Retrospective Study. Am J Clin Dermatol. 2022 Jan;23(1):105-114. doi: 10.1007/s40257-021-00637-0. Epub 2021 Oct 24.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus on Laser Treatment of Nevus of Ota in Thai Patients, 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 1 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 16 Sep 2020. 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. 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 Prof. Woraphong Manuskiatti, M.D. (+6624197000 ext. 4333, woraphong.man@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of laser treatment in paitients with Nevus of Ota (time frame: 2008-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481178, which also lists 1 linked publication.
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 16 Sep 2020.