Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-30 @ 1:00 PM
Study NCT ID:
NCT04917835
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2021-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-thermal Plasma for Sebum Reduction in Oily Facial Skin
Sponsor:
Gangnam Severance Hospital
Organization:
Study Overview
Official Title:
Assessment of Effectiveness and Safety of Non-thermal, Atmospheric-pressure Plasma (Product Name: PLADUO) for Reduction of Sebum Excretion in Oily Facial Skin.
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: