Non-thermal Plasma for Sebum Reduction in Oily Facial Skin

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Oily Skin

Treatments: Device: PLADUO(PX1000)

Study type: Interventional

Funder types: Other

Identifiers

NCT04917835

3-2019-0239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Persons aged 19 to 40 years who are determined to have oily skin type. Skin types were classified based on the sebum measurements by using measured using a Sebumeter® (SM815; Courage+Khazaka Electronic GmbH, Cologne, Germany) according to the manufacturer's guidelines as follows: > 220 μg/cm2 on forehead and > 180 μg/cm2 on cheeks, oily type; 100-220 μg/cm2 on forehead and 70-180 μg/cm2 on cheeks, normal type; < 100 μg/cm2 on forehead and < 70 μg/cm2 on cheeks, dry type.
2. People with mild acne-like skin whose upper limit is Grade 1 (Few lesions; No nodules, papules/pustules less than 1, few comedones) and Grade 2(Mild; No nodules, papules/pustules less than 5, some comedones) of the Korean acne severity system
3. Persons who skin color of type I to III according to Fitzpatrick skin type
4. Persons who do not have inflammatory skin diseases on the facial skin
5. Persons who have heard the purpose and contents of a clinical trial and voluntarily signed the consent form prior to the clinical trial
6. Persons who can be monitored during a clinical trial period

Exclusion criteria

1. Persons who do not want this study or do not write a consent form
2. Persons who have a history of hypertrophic scars, keloids, etc.
3. Persons who have been using retinoid formulations within the last 1 month due to excessive sebum secretion or acne
4. Persons who have a history of receiving treatments such as lasers or fillers on your face within the last 1 month
5. Persons who is pregnant or lactating, or have a pregnancy plan within the expected trial period
6. Other cases in which the study is considered difficult due to the judgment of the principal investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

treatment with argon- and nitrogen-NTAPP

Experimental group

Description:

PLADUO (argon- and nitrogen- non-thermal, atmospheric-pressure plasma) treatment

Treatment:

Device: PLADUO(PX1000)