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The aim of this study is to evaluate the efficacy and safety of argon-and nitrogen- non-thermal, atmospheric-pressure plasma (NTAPP) for reduction of sebum excretion in healthy volunteers with oily facial skin.
Excessive secretion of sebum contributes to several skin diseases associated with sebum glands, including acne. Excessive sebum secretion can damage the skin barrier function by changing the composition of skin surface lipids, leading to the abnormal keratinocyte differentiation and hyperkeratosis in the follicular ostia. Follicular hyperkeratosis can create anaerobic environment, leading to the proliferation of Propionibacterium acnes.
Recently, several energy devices targeting sebaceous glands have been developed, but there is still a need for an effective and safe therapeutic tool for hyperseborrhea. Non-thermal, atmospheric-pressure plasma (NTAPP) has various biological effects. A recent study demonstrated NTAPP-induced microscopic tissue reactions in the sebaceous glands from rat skin in vivo, suggesting that the potential effect of NTAPP on the human sebaceous gland physiology, but the relevant data are lacking. In this study, investigators aim to assess the safety and efficacy of argon- and nitrogen-NTAPP for reduction of sebum excretion in oily human facial skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment with argon- and nitrogen-NTAPP | Experimental | PLADUO (argon- and nitrogen- non-thermal, atmospheric-pressure plasma) treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLADUO(PX1000) | Device | Three sessions of argon- and nitrogen- NTAPP treatment at 1-week interval. Two passes of argon-NTAPP treatment and two passes of nitrogen-NTAPP treatment were sequentially performed in each session. Argon plasma at a pulse energy of 0.8 J/pulse with a 12 msec of pulse duration and nitrogen-plasma at a pulse energy of 0.75 J/pulse delivered with a 7 ms of pulse duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of casual sebum level (μg/cm 2) | The change in the casual sebum level is determined by measuring Sebumter® (SM815) from the German company Courage-khazaka. The measurement is performed in the three facial areas: forehead (mid-glabella), right and left cheeks (over the zygoma at the mid-pupillary line). | baseline, 2 weeks, 4 weeks, and 8 weeks after treatment |
| Change in the number of Ki67-and PPAR-gamma-positive sebaceous gland cells in facial tissue following treatment with argon- and nitrogen-NTAPP | Among subjects who completed the study, 2-mm skin punch biopsy specimens were obtained from zygomatic area of two volunteered subjects before and 2 weeks after argon- and nitrogen- non-thermal, atmospheric-pressure plasma treatment. | baseline and 2 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GangnamSeverance Hospital | Seoul | South Korea |
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