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OneDoc Picopulseâ„¢ is a radiopulse technology beauty grade device invented for treating melasma.
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 Picopulseâ„¢ in the future definitive trial. The findings of this study would justify OneDoc Picopulseâ„¢ as one of the promising alternative treatment for melasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Eligible patients will receive ten picopulse treatments for bi-monthly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OneDoc Picopulse | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the recruitment and measurement tools |
| Pre-treatment, two weeks and one month |
| Treatment adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Mooi Lim, PhD | Universiti Tunku Abdul Rahman | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OneDoc | Cheras | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30215845 | Result | 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. | |
| 29020467 | Result | 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. |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D008545 | Melanoma |
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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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 |
| 30320904 | Result | 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. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |