Melanoma (Skin), Skin Diseases, Skin Disorder
Conditions
Keywords
Melasma, Skin treatment, Picopulse, Malaysian women
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.
Interventions
DEVICEOneDoc 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.
Sponsors
Universiti Tunku Abdul Rahman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| Safety evaluation | immediately after and before each subsequent treatment | Incidence and severity of side effects caused by treatments |
Countries
Malaysia
Outcome results
None listed