Application of Cold Atmospheric Pressure Argon and Air Plasma to Improve the Clinical Features of the Lesions in Acne Vulgaris:Double-blind randomized clinical trial
Investigating the effectiveness of using cold argon and ambient air plasma at atmospheric pressure in healing acne vulgaris lesions
Design
The number of 24 patients in two groups (12 patients in the cold argon plasma group, 12 patients in the ambient air plasma group) based on the random list provided by the statistical analyst (the list is provided based on random blocks), undergoing eight weeks of plasma treatment They meet once a week. G*power software was used to compare two independent samples to determine the sample size.
Settings and conduct
This research is conducted in a center (University of Tehran, Skin Stem Cell Research Center). The number of 24 patients in two groups (12 patients in the cold argon plasma group, 12 patients in the ambient air plasma group) based on the random list provided by the statistical analyst (the list is provided based on random blocks), undergoing eight weeks of plasma treatment They meet once a week. Skin and Stem Cell Research Center, Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Entry criteria: female gender; age: 16 to 55 years old; Phototype I _ VI Fitzpatrick; the number of pores ≥ 10 in each half of the face; inflammatory lesions (papules and pustules) ≥ 50 in the whole face and ≥ 10 in each half of the face.
Exclusion criteria: acne conglobata; acne fulminans; secondary acne (drugs and hormones); acne requires systemic treatment.
Intervention groups
12 patients in the cold argon plasma group, 12 patients in the ambient air plasma group
Main outcome variables
Number and clinical status of different acne lesions and the size of skin pores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160514027888N1
Registration date:2022-09-11, 1401/06/20
Registration timing:prospective
Last update:2022-09-11, 1401/06/20
Update count:0
Registration date
2022-09-11, 1401/06/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 4031
Email address
m_khani@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Application of Cold Atmospheric Pressure Argon and Air Plasma to Improve the Clinical Features of the Lesions in Acne Vulgaris:Double-blind randomized clinical trial
Public title
Application of Cold Atmospheric Pressure Argon and Air Plasma to Improve the Clinical Features of the Lesions in Acne Vulgaris:Double-blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Phototype I _ VI Fitzpatrick
The number of pores ≥ 10 in each half of the face
Inflammatory lesions (papules and pustules) ≥ 50 in the whole face and ≥ 10 in each half of the face
Non-inflammatory lesions (open and closed comedones) ≥ 50 in the whole face and ≥ 10 in each half of the face
Maximum 4 nodules with a diameter ≥ 1 cm in the whole face
Atrophic scars ≥ 50 in the whole face and of any type (needle, box, rolling) ≥ 5 in each half of the face
Symmetrical distribution of lesions on both sides of the face
Age 16 to 55 years old
Gender: Female
The number of 24 patients in two groups (12 patients in the cold argon plasma group, 12 patients in the ambient air plasma group) based on the random list provided by the statistical analyst (the list is provided based on random blocks).
Patients will be treated based on the list provided (for example, the left side of the first patient will be treated using argon plasma):
1 Left Jet
2 Right Jet
3 Left Shower
4 Right Shower
5 Left Jet
6 Right Jet
7 Left Shower
8 Right Shower
9 Left Jet
10 Right Jet
11 Left Shower
12 Right Shower
13 Left Jet
14 Right Jet
15 Left Shower
16 Right Shower
17 Left Jet
18 Right Jet
19 Left Shower
20 Right Shower
21 Left Jet
22 Right Jet
23 Left Shower
24 Right Shower
How to randomize and blind
Blinding (investigator's opinion)
Double blinded
Blinding description
Clients are selected from a random list that the operator and dermatologists cannot access. In one group, for 10 minutes, half of the person's face on one side (except the nose) is subjected to atmospheric cold plasma precipitation (shower-plasma shower-precipitation plasma), and the other is passed with the device in off mode. The patient does not know that the device is off way. In the second group, argon gas is used instead of air. Weekly visits and the duration of treatment are eight weeks.
The previous design samples immediately after follow-up weeks 1, 2, 3, 4, and 8 are subjected to skin analysis and biometrics.
Placebo
Not used
Assignment
Parallel
Other design features
In order to determine the sample size for comparing two independent samples using G*power software and considering the significance level of 0.05 and the power of 0.8 and the effect size = 1.2 which is the large effect value and the ratio Assignment 1, the output of the software is as follows:Output:Sample size group 1 = 12Sample size group 2 = 12Total sample size = 24Actual power = 0.8020788
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine - Tehran University of Medical Sciences (Research Ethics Committee)
Street address
Enghebal St. - Quds St. - Porsina St. - University North Door - Building No. 1
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-12-26, 1400/10/05
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1135
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Pour and their size in each visit
Timepoint
Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment.
Method of measurement
They are measured and recorded by the SKIN SCANNER device.
2
Description
Scars and their size
Timepoint
Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment.
Method of measurement
They are measured and recorded by the SKIN SCANNER device.
3
Description
Inflammatory and non-inflammatory acne lesions
Timepoint
Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment.
Method of measurement
They are measured and recorded by the SKIN SCANNER device.
4
Description
Acne severity
Timepoint
Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment.
Method of measurement
They are measured and recorded by the SKIN SCANNER device.
5
Description
Examination of skin roughness
Timepoint
Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment.
Method of measurement
They are measured and recorded by the SKIN SCANNER device.
6
Description
Skin biometric parameters
Timepoint
Variables are measured before, immediately after, one week, two weeks, three weeks, four weeks and eight weeks after the start of treatment.
Method of measurement
This item is quantitatively measured and reported by CUTOMETER and MPA 9 devices.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Argon plasma. In this method, an argon plasma device manufactured by Danesh Banyan Engineering Plasma Technology Co., Ltd. is used to process acne. In this method, the cold flame of the plasma will be shone on the acnes of one half of the face and compared with the other half of the face. This group is treated for eight weeks and one session per week.
Category
Treatment - Devices
2
Description
Second intervention group: air plasma. In this method, air plasma device manufactured by Danesh Banyan Engineering Plasma Technology Company is used to process acne. In this method, the same as the first intervention group, the process of plasma irradiation is performed.
Category
Treatment - Devices
3
Description
Control group: placebo. In this group, the other half of the face is processed by the probes of the device in the off state (the gas flow is open without electricity connection to form plasma in this group) and all the mentioned parameters are measured and recorded as in the plasma groups. .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Ali Nilforoshzadeh
Street address
No. 4, Maryam Ave, South Kamraniye
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 2267 1008
Email
nilforoosh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8899 2970
Email
afotouhi@tums.ac.ir
Web page address
http://www.tums.ac.ir/faculties/afotouhi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
72
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Babak Shokri
Street address
Evin Shahid beheshti university
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 4001
Email
b-shokri@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
Proportion provided by this source
28
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Laser and Plasma Research Institute/ Shahid Beheshti University