NCT04834167

Brief Summary

OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

March 24, 2021

Last Update Submit

November 29, 2023

Conditions

Skin DiseasesSkin DisorderMelanoma (Skin)

Keywords

MelasmaSkin treatmentPicopulseMalaysian women

Outcome Measures

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)

    One month

Secondary Outcomes (5)

  • Feasibility of the recruitment and measurement tools

    Pre-treatment, two weeks and one month

  • Treatment adherence

    five months

  • Melasma

    Through study completion, an average of 24 weeks

  • Quality of life of patients

    Pre-treatment, two weeks and one month post-treatment

  • Safety evaluation

    immediately after and before each subsequent treatment

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: OneDoc Picopulse

Interventions

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.

Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OneDoc

Cheras, Malaysia

Location

Related Publications (3)

  • 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.

    PMID: 30215845RESULT

  • 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.

    PMID: 29020467RESULT

  • 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.

    PMID: 30320904RESULT

MeSH Terms

Conditions

Skin DiseasesMelanomaMelanosis

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteHyperpigmentationPigmentation Disorders

Study Officials

  • Yang Mooi Lim, PhD

    Universiti Tunku Abdul Rahman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director (Institute of Postgraduate Studies and Research), Professor

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 8, 2021

Study Start

May 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)