Oily SkinNCT04917835
Non-thermal Plasma for Sebum Reduction in Oily Facial Skin
A study testing PLADUO(PX1000) in people with Oily Skin, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Oily Skin
- What is being tested?
- PLADUO(PX1000)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2019to 6 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Oily Skin
- Being tested
- PLADUO(PX1000)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment with argon- and nitrogen-NTAPP | Experimental | PLADUO (argon- and nitrogen- non-thermal, atmospheric-pressure plasma) treatment Receives: Device: PLADUO(PX1000) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: baseline and 2 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start15 Nov 2019
- Primary completion9 Apr 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oily SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Eun Lee, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917835
- Sponsor's protocol ID
- 3-2019-0239
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04917835
- Acronym / sponsor ID
- 3-2019-0239
- Conditions
- Oily Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment with argon- and nitrogen-NTAPP | Experimental | Device: PLADUO(PX1000)PLADUO (argon- and nitrogen- non-thermal, atmospheric-pressure plasma) treatment |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLADUO(PX1000)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. | Device | treatment with argon- and nitrogen-NTAPP |
Primary outcome
Measurement of casual sebum level (μg/cm 2)
Time frame: baseline, 2 weeks, 4 weeks, and 8 weeks after treatment
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).
Change in the number of Ki67-and PPAR-gamma-positive sebaceous gland cells in facial tissue following treatment with argon- and nitrogen-NTAPP
Time frame: baseline and 2 weeks after treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLADUO(PX1000) in people with Oily Skin, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of casual sebum level (μg/cm 2) (time frame: baseline, 2 weeks, 4 weeks, and 8 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.