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Safety and efficacy assessment of “Synskin Acnes 2 acute phase cream” and “Synskin Acnes 3 chronic phase cream” for treatment of mild to moderate acne vulgaris

Protocol summary

Study aim
Safety and efficacy assessment of “Synskin Acnes 2 acute phase cream” and “Synskin Acnes 3 chronic phase cream” for treatment of mild to moderate acne vulgaris
Design
Single group, phase 2, before -after clinical study. sample size is 20. The study is not randomized.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 20 volunteers with acne vulgaris will be selected and enrolled in the study after signing consent form. Volunteers will be taught to use “Synskin Acnes 2 acute phase cream” for 2 weeks and “Synskin Acnes 3 chronic phase cream” from 3th to10th week twice a day. Before intervention and at the end of 2,6 and10 weeks later changing in skin will be measured. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female aged 16-40 years, Mild to moderate inflammatory or non-inflammatory acne lesions (grade 1 to 3 according to the table) on face Exclusion criteria: People with allergies to formulation ingredients, Nodular or cystic lesions that represent a severe type of acne vulgaris
Intervention groups
Topical use of “Synskin Acnes 2 acute phase cream” (Contains anti-acne compounds such as Tea tree extract, Niacin amid, Vitamin A, etc..) for 2 weeks twice a day and then “Synskin Acnes 3 chronic phase cream”(Contains Niacin amid, Vitamin A,Canadian willow extract, etc..) for 8 weeks.
Main outcome variables
Evaluate the improvement of acne severity index by a physician based on: 0=normal skin, 2=skin is almost clear, 3=some non-inflammatory lesions are present, 4=non-inflammatory lesions are predominant, with multiple inflammatory lesions. 5=highly inflammatory lesions predominate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190210042676N14
Registration date: 2021-06-11, 1400/03/21
Registration timing: prospective

Last update: 2021-06-11, 1400/03/21
Update count: 0
Registration date
2021-06-11, 1400/03/21
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy assessment of “Synskin Acnes 2 acute phase cream” and “Synskin Acnes 3 chronic phase cream” for treatment of mild to moderate acne vulgaris
Public title
Safety and efficacy assessment of Synskin “ Acnes 2 cream” and “ Acnes 3 cream” for treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female aged 16-40 years Mild to moderate inflammatory or non-inflammatory acne lesions (grade 1 to 3 according to the table) on face
Exclusion criteria:
People with allergies to formulation ingredients Nodular or cystic lesions that represent a severe type of acne vulgaris
Age
From 16 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-02-01, 1399/11/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1038

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
Evaluate the improvement of acne severity index by a physician
Timepoint
Before intervention, 2, 6 and 10 weeks after the start of use
Method of measurement
0=normal skin, 2=skin is almost clear, 3=some non-inflammatory lesions are present, 4=non-inflammatory lesions are predominant, with multiple inflammatory lesions. 5=highly inflammatory lesions predominate

Secondary outcomes

1

Description
Trans Epidermal Water Loss
Timepoint
Before intervention, 2, 6 and 10 weeks after the start of use
Method of measurement
Tewameter

2

Description
Skin sebum
Timepoint
Before intervention, 2, 6 and 10 weeks after the start of use
Method of measurement
Sebumeter

Intervention groups

1

Description
Intervention group: Topical use of “Synskin Acnes 2 acute phase cream” (Contains anti-acne compounds such as Tea tree extract, Niacin amid, Vitamin A, etc..) for 2 weeks twice a day and then “Synskin Acnes 3 chronic phase cream”(Contains Niacin amid, Vitamin A,Canadian willow extract, etc..) for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy
Full name of responsible person
Aniseh Samadi
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
dermalab@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran Avandfar Company
Full name of responsible person
Nader Soltani Hoseini
Street address
No.80 ,Baqerkhan Ave. ,Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1441764181
Phone
+98 21 6642 2655
Email
info@iranbath.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Avandfar Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
Manger of clinical study unit
Latest degree
Ph.D.
Other areas of specialty/work
Skin Biometrics
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
aniseh_samadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Professor of dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 7921
Email
firozali@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Clinical Research
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
ahmadi.maryam648@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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