OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

Not Applicable

Completed

• Conditions: Skin Disorder; Melanoma (Skin); Skin Diseases
• Interventions: Device: OneDoc Picopulse

• Registration Number: NCT04834167
• Lead Sponsor: Universiti Tunku Abdul Rahman

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.

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-08
• Study Start: 2021-05-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	OneDoc Picopulse	Eligible patients will receive ten picopulse treatments for bi-monthly.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Feasibility of the recruitment and measurement tools	Pre-treatment, two weeks and one month	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)
Treatment adherence	five months	Number of treatments attended
Safety evaluation	immediately after and before each subsequent treatment	Incidence and severity of side effects caused by treatments
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

Trial Locations

Locations (1)

OneDoc; 🇲🇾 Cheras, Malaysia