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CompletedNCT04834167Updated Nov 30, 2023

OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

An interventional study of OneDoc Picopulse in Skin Diseases, Skin Disorder and Melanoma (Skin), sponsored by Universiti Tunku Abdul Rahman. Completed at 1 site in Malaysia. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by Universiti Tunku Abdul Rahman · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
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Study summary

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.

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Conditions studied

  • Skin Diseases
  • Skin Disorder
  • Melanoma (Skin)

Keywords

  • Melasma
  • Skin treatment
  • Picopulse
  • Malaysian women
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In context

Skin Diseases

538 studies on the registry are indexed under Skin Diseases; 92 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 372 interventional studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

Universiti Tunku Abdul Rahman is the lead sponsor of 35 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women presenting dermal melasma with Fritzpatrick skin type III to V
  • Malaysian citizen
  • Agreed to participate
  • Provide informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Treatment

    Eligible patients will receive ten picopulse treatments for bi-monthly.

    Device: OneDoc Picopulse

Interventions

  • DeviceOneDoc Picopulse

    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.

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: One month

Secondary outcomes

  1. Feasibility of the recruitment and measurement tools

    1. Number of patients referred from OneDoc and eligible for screening 2. Number of patients recruited 3. Follow-up response rates (2 weeks and 1 month follow-ups)

    Time frame: Pre-treatment, two weeks and one month

  2. Treatment adherence

    Number of treatments attended

    Time frame: five months

  3. Melasma

    Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma)

    Time frame: Through study completion, an average of 24 weeks

  4. 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

    Time frame: Pre-treatment, two weeks and one month post-treatment

  5. Safety evaluation

    Incidence and severity of side effects caused by treatments

    Time frame: immediately after and before each subsequent treatment

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Study locations

1 site
  • OneDoc
    Cheras, Malaysia
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References and documents

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 30215845 ↗
  • Chalermchai 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 29020467 ↗
  • Labadie 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04834167
Lead sponsor
Universiti Tunku Abdul Rahman
Responsible party
Yang Mooi Lim (Deputy Director (Institute of Postgraduate Studies and Research), Professor, Universiti Tunku Abdul Rahman) — Principal investigator
First posted
Apr 8, 2021
Start date
May 1, 2021
Primary completion
Dec 1, 2022
Completion
Dec 1, 2022
Last update
Nov 30, 2023

Study contacts

Yang Mooi Lim, PhD
principal investigator · Universiti Tunku Abdul Rahman

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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