OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

Study Overview
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Brief Summary
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OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma.

Detailed Description
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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.

Official Title
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OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

Conditions
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Skin Diseases, Skin Disorder, Melanoma (Skin)

Intervention / Treatment
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* Device: OneDoc Picopulse


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Eligible patients will receive ten picopulse treatments for bi-monthly. | Device: OneDoc Picopulse<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Pre-treatment, two weeks and one month | 
| Treatment adherence | Number of treatments attended | five months | 
| Melasma | Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma) | Through study completion, an average of 24 weeks | 
| 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 | Pre-treatment, two weeks and one month post-treatment | 
| Safety evaluation | Incidence and severity of side effects caused by treatments | immediately after and before each subsequent treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melasma, Skin treatment, Picopulse, Malaysian women