Skin DiseasesNCT04834167
OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
A study testing OneDoc Picopulse in people with Skin Diseases and Skin Disorder, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
Trial summary
OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Skin Diseases, Skin Disorder, Melanoma (Skin)
- What is being tested?
- OneDoc Picopulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2021to 1 Dec 2022
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women presenting dermal melasma with Fritzpatrick skin type III to V
- Malaysian citizen
- Agreed to participate
- Provide informed consent
Who cannot join
- Patients who had a laser procedure, phototherapy therapy, peel, oral therapy, topical treatment or used lightening creams in the treatment area within the past 6 months.
- Patients with pregnancy, lactating, active dermatitis, had a history of immunosuppression/immune deficiency disorders
- Patients who photosensitivity or taking drugs known to induce photosensitivity,
- Patients that have been exposed to severe sun exposure, having severe epidermal injury, allergy and sensitivity
- Patients who could not attend follow-up treatments
Trial locations and contacts
1 site in 1 country.
About this study
OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma.
Read the detailed description
This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial. The findings of this study would justify OneDoc Picopulse™ as one of the promising alternative treatment for melasma.
- Conditions
- Skin Diseases, Skin Disorder, Melanoma (Skin)
- Being tested
- OneDoc Picopulse
- Keywords
- Melasma, Skin treatment, Picopulse, Malaysian women
- Medical subject headings
- Skin Diseases, Melanoma, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneDoc PicopulseDevice
Eligible patients will proceed to receive skin cleansing prior to OneDoc Picopulse treatment. After the cleansing, the patients will receive OneDoc Picopulse treatment for 15 mins. Patients will receive ten picopulse treatments for bi-monthly.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Eligible patients will receive ten picopulse treatments for bi-monthly. Receives: Device: OneDoc Picopulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the treatment
Short Assessment of Patient Satisfaction (SAPS) questionnaire with additional Qualitative data collection; The score range for SAPS is from 0 (extremely dissatisfied) to 28 (extremely satisfied)
Measured: One month
Secondary outcomes (5)
Feasibility of the recruitment and measurement tools
- Number of patients referred from OneDoc and eligible for screening
- Number of patients recruited
- Follow-up response rates (2 weeks and 1 month follow-ups)
Measured: Pre-treatment, two weeks and one month
Treatment adherence
Number of treatments attended
Measured: five months
Melasma
Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma)
Measured: Through study completion, an average of 24 weeks
Quality of life of patients
Melasma Quality of Life Scale (MELASQOL) score ranges from 10 to 70; Higher the score, worse is the quality of life
Measured: Pre-treatment, two weeks and one month post-treatment
Safety evaluation
Incidence and severity of side effects caused by treatments
Measured: immediately after and before each subsequent treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Mooi Lim, Universiti Tunku Abdul Rahman
- Investigators
- Yang Mooi Lim, PhD, Principal investigator, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834167
- Sponsor's protocol ID
- UTAR-45-2021
- Status last verified
- Nov 2023
- First submitted
- 24 Mar 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amini F, Thazin Oo NM, Okechukwu PN, Seghayat MS, Ng ESC. Polymorphisms in P53 and VEGFA genes in different subtypes of periorbital hyperpigmentation in a Malaysian Chinese population. Australas J Dermatol. 2019 May;60(2):e99-e104. doi: 10.1111/ajd.12918. Epub 2018 Sep 14.
PubMed 30215845Chalermchai T, Rummaneethorn P. Effects of a fractional picosecond 1,064 nm laser for the treatment of dermal and mixed type melasma. J Cosmet Laser Ther. 2018 Jun;20(3):134-139. doi: 10.1080/14764172.2017.1376098. Epub 2017 Dec 4.
PubMed 29020467Labadie JG, Krunic AL. Long pulsed dye laser with a back-to-back double-pulse technique and compression for the treatment of epidermal pigmented lesions. Lasers Surg Med. 2019 Feb;51(2):136-140. doi: 10.1002/lsm.23009. Epub 2018 Oct 15.
PubMed 30320904
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
- ClinicalTrials.gov ID
- NCT04834167
- Acronym / sponsor ID
- UTAR-45-2021
- Conditions
- Skin Diseases, Skin Disorder, Melanoma (Skin)
- Keywords
- Melasma, Skin treatment, Picopulse, Malaysian women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 8 Apr 2021 (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.
OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma.
Detailed description
This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial. The findings of this study would justify OneDoc Picopulse™ as one of the promising alternative treatment for melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: OneDoc PicopulseEligible patients will receive ten picopulse treatments for bi-monthly. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women presenting dermal melasma with Fritzpatrick skin type III to V
- Malaysian citizen
- Agreed to participate
- Provide informed consent
Key exclusion criteria (5 listed)
- Patients who had a laser procedure, phototherapy therapy, peel, oral therapy, topical treatment or used lightening creams in the treatment area within the past 6 months.
- Patients with pregnancy, lactating, active dermatitis, had a history of immunosuppression/immune deficiency disorders
- Patients who photosensitivity or taking drugs known to induce photosensitivity,
- Patients that have been exposed to severe sun exposure, having severe epidermal injury, allergy and sensitivity
- Patients who could not attend follow-up treatments
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 |
|---|---|---|
| OneDoc PicopulseEligible patients will proceed to receive skin cleansing prior to OneDoc Picopulse treatment. After the cleansing, the patients will receive OneDoc Picopulse treatment for 15 mins. Patients will receive ten picopulse treatments for bi-monthly. | Device | Treatment |
Primary outcome
Acceptability of the treatment
Time frame: One month
Short Assessment of Patient Satisfaction (SAPS) questionnaire with additional Qualitative data collection; The score range for SAPS is from 0 (extremely dissatisfied) to 28 (extremely satisfied)
5 secondary outcomes
Feasibility of the recruitment and measurement tools
Time frame: Pre-treatment, two weeks and one month
Treatment adherence
Time frame: five months
Melasma
Time frame: Through study completion, an average of 24 weeks
Quality of life of patients
Time frame: Pre-treatment, two weeks and one month post-treatment
Safety evaluation
Time frame: immediately after and before each subsequent treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Results publication: PubMed 30215845Amini F, Thazin Oo NM, Okechukwu PN, Seghayat MS, Ng ESC. Polymorphisms in P53 and VEGFA genes in different subtypes of periorbital hyperpigmentation in a Malaysian Chinese population. Australas J Dermatol. 2019 May;60(2):e99-e104. doi: 10.1111/ajd.12918. Epub 2018 Sep 14.
- Results publication: PubMed 29020467Chalermchai T, Rummaneethorn P. Effects of a fractional picosecond 1,064 nm laser for the treatment of dermal and mixed type melasma. J Cosmet Laser Ther. 2018 Jun;20(3):134-139. doi: 10.1080/14764172.2017.1376098. Epub 2017 Dec 4.
- Results publication: PubMed 30320904Labadie JG, Krunic AL. Long pulsed dye laser with a back-to-back double-pulse technique and compression for the treatment of epidermal pigmented lesions. Lasers Surg Med. 2019 Feb;51(2):136-140. doi: 10.1002/lsm.23009. Epub 2018 Oct 15.
- Individual participant dataSharing planned: No
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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.
Yang Mooi Lim, PhD principal investigator
Universiti Tunku Abdul Rahman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OneDoc Picopulse in people with Skin Diseases and Skin Disorder, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Nov 2023. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the treatment (time frame: One month). 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 NCT04834167, which also lists 3 linked publications.
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 30 Nov 2023.