Evaluation of the effect of topical formulation prepared from hydroalcoholic extract of Arctium Lappa's root in the treatment of mild and moderate Acne Vulgaris
Evaluation of the efficacy of topical formulation of Arctium Lappa extract in the treatment of acne vulgaris
Design
Patients undergo a phase 3 trial with the help of a list provided by randomization.com, divided into intervention and control groups and receiving treatment in parallel for each group.
Settings and conduct
Patients are examined by a physician after signing an informed consent form by attending the dermatology clinic of Imam Reza Hospital and receive the appropriate treatment randomly.
Participants/Inclusion and exclusion criteria
Women and men 12 to 30 years with acne vulgaris and no other systemic or skin diseases
Intervention groups
Patients were randomly divided into intervention and control groups, the intervention group using topical tretinoin and Arctium Lappa each day on the face; the control group used topical tretinoin twice daily on the face. Finally, the rate of improvement in skin lesions in these two groups was compared after three months of drug administration.
Main outcome variables
improvement of acne vulgaris lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191111045408N1
Registration date:2019-11-24, 1398/09/03
Registration timing:prospective
Last update:2019-11-24, 1398/09/03
Update count:0
Registration date
2019-11-24, 1398/09/03
Registrant information
Name
Amirreza Entezari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4333 4374
Email address
entezariar941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2021-01-14, 1399/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical formulation prepared from hydroalcoholic extract of Arctium Lappa's root in the treatment of mild and moderate Acne Vulgaris
Public title
Evaluation of the effect of formulation Arctium Lappa in the treatment of Mild-to-moderate Acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women and men aged 12-30 years with mild to moderate acne vulgaris
Have signed the informed consent form
Exclusion criteria:
Pregnant or breastfeeding or planning to become pregnant
Have a history of sensitivity to the components of the formulations used in the study
Other skin diseases such as eczema that make it difficult to evaluate the response to treatment
Have uncontrolled systemic disease
They have Acne Conglobata
Not taking the following drugs before starting the plan (topical anti-acne drugs for two weeks, oral antibiotics for one month, 12 weeks hormone therapy and 6 months oral retinoids).
Age
From 12 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Use simple randomization with the help of a listing provided by randomization.com
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, 100 patients with mild-to-moderate acne vulgaris referred to the special clinic of Ghaem Hospital, Mashhad, who met the inclusion criteria, will be enrolled after obtaining informed consent. Patients in groups A and B receive tretinoin gel, and then patients are randomly assigned to group A or B and receive placebo gel (B) or Arctium Lappa's gel (A) with tretinoin gel. Patients in groups C and D also receive tretinoin cream, which in turn will receive cream containing Arctium Lappa (C) or placebo (D). The first 50 patients will be divided between groups A and B and the next 50 patients will be divided between groups C and D. The placebo and herbal formulations will be delivered in the same package to the patients, which will have a very similar appearance and will be prepared by an individual other than the treating physician and the evaluating pharmacy student, distinguished only by the letters A, B, C or D, and The physician, pharmacy student, patient, and analyzer will remain unaware of the formulation until the work is completed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad,Daneshgah Ave,Central Organization of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2019-09-21, 1398/06/30
Ethics committee reference number
IR.MUMS.REC.1398.180
Health conditions studied
1
Description of health condition studied
َAcne Vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris (or simply acne) is a long-term skin disease that occurs when hair follicles become clogged with dead skin cells and oil from the skin. Acne is characterized by areas of blackheads, whiteheads, pimples, and greasy skin, and may result in sca
Primary outcomes
1
Description
Acne Complication
Timepoint
One month after intervention, two months after intervention, three months after intervention
Method of measurement
Based on acne lesion counting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical tretinoin formulation and Arctium Lappa topical formulation are applied once daily for three months on face skin.
Category
Treatment - Drugs
2
Description
Control group: Topical application of tretinoin twice daily for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Sepideh Elyasi
Street address
Imam Reza Square, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
support@rpsi.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqodi
Street address
VakilAbad Blvd, School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1100
Email
hassanzadehmm1@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Entezari
Position
Pharmacy Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
VakilAbad Blvd, School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1100
Email
entezariar941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
VakilAbad Blvd, School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
31801100 051
Email
elyasis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Entezari
Position
Student of Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
VakilAbad Blvd, School of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
31801100 051
Email
entezariar941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information listed will be published in the form of an article.
When the data will become available and for how long
The article will be available through Infinite Journal.
To whom data/document is available
Anyone who needs them can access.
Under which criteria data/document could be used
The data not published in this article will be provided in coordination with all project partners and research assistants of Mashhad University of Medical Sciences.
From where data/document is obtainable
Email the person in charge
What processes are involved for a request to access data/document
The consent of all research associates of Mashhad University of Medical Sciences should be obtained.