Oily Skin Clinical Trial
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.
Verified date | June 2021 |
Source | Gangnam Severance Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | May 6, 2020 |
Est. primary completion date | April 9, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | GangnamSeverance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Gangnam Severance Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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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