Non-thermal Plasma for Sebum Reduction in Oily Facial Skin

NCT04917835 | Completed

• 1 other identifier: 3-2019-0239
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Oily Skin

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

treatment with argon- and nitrogen-NTAPP

EXPERIMENTAL

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

Device: PLADUO(PX1000)

Interventions

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.

treatment with argon- and nitrogen-NTAPP

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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
• Persons who skin color of type I to III according to Fitzpatrick skin type
• Persons who do not have inflammatory skin diseases on the facial skin
• Persons who have heard the purpose and contents of a clinical trial and voluntarily signed the consent form prior to the clinical trial
• Persons who can be monitored during a clinical trial period

You may not qualify if:

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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 8, 2021
• Study Start: November 15, 2019
• Primary Completion: April 9, 2020
• Study Completion: May 6, 2020
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

KR (1)