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OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

Primary Purpose

Skin Diseases, Skin Disorder, Melanoma (Skin)

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
OneDoc Picopulse
Sponsored by
Universiti Tunku Abdul Rahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases focused on measuring Melasma, Skin treatment, Picopulse, Malaysian women

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • OneDocRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Treatment adherence
Number of treatments attended
Melasma
Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma)
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
Safety evaluation
Incidence and severity of side effects caused by treatments

Full Information

First Posted
March 24, 2021
Last Updated
May 24, 2022
Sponsor
Universiti Tunku Abdul Rahman
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1. Study Identification

Unique Protocol Identification Number
NCT04834167
Brief Title
OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
Official Title
OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Tunku Abdul Rahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Skin Disorder, Melanoma (Skin)
Keywords
Melasma, Skin treatment, Picopulse, Malaysian women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Eligible patients will receive ten picopulse treatments for bi-monthly.
Intervention Type
Device
Intervention Name(s)
OneDoc Picopulse
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of the treatment
Description
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 Outcome Measure Information:
Title
Feasibility of the recruitment and measurement tools
Description
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)
Time Frame
Pre-treatment, two weeks and one month
Title
Treatment adherence
Description
Number of treatments attended
Time Frame
five months
Title
Melasma
Description
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
Title
Quality of life of patients
Description
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
Title
Safety evaluation
Description
Incidence and severity of side effects caused by treatments
Time Frame
immediately after and before each subsequent treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women presenting dermal melasma with Fritzpatrick skin type III to V Malaysian citizen Agreed to participate Provide informed consent 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Mooi Lim, PhD
Phone
60390860288
Email
ymlim@utar.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Chai Nien Foo, PhD
Phone
60390860288
Email
foocn@utar.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Mooi Lim, PhD
Organizational Affiliation
Universiti Tunku Abdul Rahman
Official's Role
Principal Investigator
Facility Information:
Facility Name
OneDoc
City
Cheras
Country
Malaysia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30215845
Citation
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.
Results Reference
result
PubMed Identifier
29020467
Citation
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.
Results Reference
result
PubMed Identifier
30320904
Citation
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.
Results Reference
result

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OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

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