OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

• Sponsor: Universiti Tunku Abdul Rahman (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04834167
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Skin Diseases; Skin Disorder; Melanoma (Skin)	Device: OneDoc Picopulse	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Eligible patients will receive ten picopulse treatments for bi-monthly.	Device: OneDoc 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.

Outcome Measures

Primary Outcome Measures

1. Acceptability of the treatment [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)

Secondary Outcome Measures

1. Feasibility of the recruitment and measurement tools [Pre-treatment, two weeks and one month]

   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)

2. Treatment adherence [five months]

   Number of treatments attended

3. Melasma [Through study completion, an average of 24 weeks]

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

4. Quality of life of patients [Pre-treatment, two weeks and one month post-treatment]

   Melasma Quality of Life Scale (MELASQOL) score ranges from 10 to 70; Higher the score, worse is the quality of life

5. Safety evaluation [immediately after and before each subsequent treatment]

   Incidence and severity of side effects caused by treatments

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OneDoc	Cheras		Malaysia

Sponsors and Collaborators

• Universiti Tunku Abdul Rahman

Investigators

• Principal Investigator: Yang Mooi Lim, PhD, Universiti Tunku Abdul Rahman

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yang Mooi Lim, Deputy Director (Institute of Postgraduate Studies and Research), Professor, Universiti Tunku Abdul Rahman
• ClinicalTrials.gov Identifier: NCT04834167
• Other Study ID Numbers: UTAR-45-2021
• First Posted: Apr 8, 2021
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yang Mooi Lim, Deputy Director (Institute of Postgraduate Studies and Research), Professor, Universiti Tunku Abdul Rahman: Melasma; Skin treatment; Picopulse; Malaysian women
• Additional relevant MeSH terms: Skin Diseases; Melanosis

Study Results

No Results Posted as of May 31, 2022