Evaluation of the efficacy of topical solution containing 80% sulfur dioxide, 10% extract of myrtus communis and 10% extract of saffron on the treatment of benign skin lesions; moles, warts and seborrheic keratosis.
Design
This study is a non-randomized clinical trial without a control group. patients are selected using convinience sampling. The minimum sample size is 64 according to previous studies (19 patients with moles, 25 warts and 20 seborrheic keratoses).
Settings and conduct
Among patients who visit the physician's office those whose skin lesions are confirmed by clinical examination are enrolled in the study. After obtaining written consent a punch biopsy is obtained prior to the treatment.
After the treatment period (about three weeks later), another punch biopsy is obtained. Patients are visited in 4, 8, and 12 weeks later to determine the recurrence rate.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients whose skin lesions (Moles, Warts or Seborrheic Keratosis) are confirmed by a physician following a clinical examination.
Exclusion criteria: Patient with suspected malignant lesions. Presence of wounds or other active skin disease.
Intervention groups
Intervention group: After type of the lesion is confirmed, a treatment solution containing 80% sulfur dioxide, 10% extract of myrtus communis and 10% extract of saffron is placed topically on the lesion by the physician. The solution is produced by Zojaj Darman Toos pharmaceutical company . If necessary, the treatment session is repeated with the presence of the physician. Patients are not charged for treatment, visits, or tests.
Main outcome variables
Lesion size; pathology report
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151230025772N7
Registration date:2020-04-04, 1399/01/16
Registration timing:registered_while_recruiting
Last update:2020-04-04, 1399/01/16
Update count:0
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Seyyed Abbas Zojaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2717
Email address
zojajia881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy of Topical Modified Sulfur Dioxide on the Treatment of Benign Skin Lesions; Moles, Warts and Seborrheic Keratosis
Public title
Effect of Sulfur in treatment of Moles, Warts and Seborrheic Keratosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whose skin lesions (Moles, Warts or Seborrheic Keratosis) are confirmed by a physician following a clinical examination.
Exclusion criteria:
Suspected of malignant lesions
Presence of wounds or other active skin disease
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
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 Islamic Azad University - Mashhad Branch
Street address
Dr Shahinfar Medical Faculty, Sarab Alley., Imam Khomeimi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2019-08-26, 1398/06/04
Ethics committee reference number
IR.IAU.MSHD.REC.1398.231
Health conditions studied
1
Description of health condition studied
Mole (Melanocytic nevi)
ICD-10 code
D22
ICD-10 code description
Melanocytic nevi
2
Description of health condition studied
wart
ICD-10 code
B07
ICD-10 code description
Viral warts
3
Description of health condition studied
seborrheic keratosis
ICD-10 code
L82
ICD-10 code description
Seborrheic keratosis
Primary outcomes
1
Description
Size of the lesion
Timepoint
Baseline (before intervention), 3, 7, 11, and 15 weeks after treatment.
Method of measurement
Clinical examination
2
Description
Pathology report
Timepoint
Baseline (before intervention), 3, 7, 11, and 15 weeks after treatment.
Method of measurement
Pathology examination of the lesion`s punch biopsy by a specialist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After type of the lesion is confirmed, a treatment solution containing 80% sulfur dioxide, 10% extract of myrtus communis and 10% extract of saffron is placed topically on the lesion by the physician. The solution is produced by Zojaj Darman Toos pharmaceutical company . If necessary, the treatment session is repeated with the presence of the physician. Patients are not charged for treatment, visits, or tests.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farnoosh Bidouee`s Office
Full name of responsible person
Farnoosh Bidouee
Street address
Dr Bidouee`s Office, No. 758, Between Moalem 30 and 32, Moalem Blvd, Mashhad City.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188996118
Phone
+98 51 3605 5668
Email
Fah22ba@yahoo.com
2
Recruitment center
Name of recruitment center
Farnoosh Bidouee`s Office 2
Full name of responsible person
Farnoosh Bidouee
Street address
Dr Bidouee`s Office, No. 834, Between Sanabad 58 and 60, Sanabad Street, Mashhad City.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185678577
Phone
+98 51 3846 0022
Email
Fah22ba@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeed Abtahi
Street address
Shahinfar Faculty of Medicine, Imam Khomeini Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3225 6291
Email
IMRC@mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Farnoosh Bidouee
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
Islamic Azad University
Full name of responsible person
Farnoosh Bidouee
Position
Non-Academic Specialist Physician
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Shahinfar Faculty of Medicine, Imam Khomeini Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3225 6291
Email
Fah22ba@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farnoosh Bidouee
Position
Non-Academic Specialist Physician
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Shahinfar Faculty of Medicine, Imam Khomeini Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3225 6291
Email
Fah22ba@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farnoosh Bidouee
Position
Non-Academic Specialist Physician
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Shahinfar Faculty of Medicine, Imam Khomeini Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3225 6291
Email
Fah22ba@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available