Evaluation of the effectiveness of Dorema ammoniacum gum in the treatment of skin warts Compared to salicylic acid
Design
Two arm parallel group randomised trial with control group
Settings and conduct
The study will be performed in Sedigheh Tahereh Research Center of Isfahan. Patients with inclusion criteria will be randomly assigned to drug or control groups. The sample size is 44 patients. For patients in drug group, a topical product of Dorema ammoniacum gum will be applied for two weeks, while for patients of control group, 40% salicylic acid solution will be used for two weeks. At the end of days 14 and 28 (end of intervention) of intervention, the percent of wart size reduction will be recorded. Furthermore, the number of cases with complete wart healing during the study will be recorded for both groups. Finally, the mentioned variables will be compared between the groups.
Participants/Inclusion and exclusion criteria
Age of 18 years or more
Less than 5 common or plantar warts
Entry : No treatment for anti-wart during the last 30 days
No underlying skin disease except warts
Pregnancy
Lactation
Lack of underlying safety
Intervention groups
Drug Group: Dorema ammoniacum topical product , Isfahan University of Medical Sciences, Isfahan University of Medical Sciences, Twice a day with daily washing of the lesion for 14 days Control group: 40% salicylic acid solution prepared from a pharmacy
Main outcome variables
1. The percent change in the wart size 2. The number of cases of complete size change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N20
Registration date:2021-09-02, 1400/06/11
Registration timing:prospective
Last update:2021-09-02, 1400/06/11
Update count:0
Registration date
2021-09-02, 1400/06/11
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Dorema ammoniacum gum in the treatment of skin warts Compared to salicylic acid
Public title
The effectiveness of Dorema ammoniacum gum in the treatment of skin warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 years or more
Less than 5 common or plantar warts
No treatment for anti-wart during the last 30 days
No underlying skin disease except warts
Exclusion criteria:
Pregnancy
Lactation
Lack of underlying safety
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
All the arrangements of the two groups will be drawn in pairs in quadruple blocks and each block will be numbered from 1 to the end. Using a table of random numbers, the blocks are selected in order and based on the arrangement of that block, patients will be divided into one of two groups according to the order of admission.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-chancellery for research, Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.804
Health conditions studied
1
Description of health condition studied
Common or plantar warts
ICD-10 code
B07.0
ICD-10 code description
Plantar wart
Primary outcomes
1
Description
Percentage change in wart size at the end of the intervention 2. Change the number of warts at the end of the intervention
Timepoint
Before the intervention, 14 and 28 days after the start of intervention
Method of measurement
Ruler
Secondary outcomes
1
Description
Number of people with complete recovery at the end of the intervention
Timepoint
The beginning of the intervention 14 and 28 days after the intervention
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Dorema ammoniacum topical product , Isfahan University of Medical Sciences, Isfahan University of Medical Sciences, Twice a day with daily washing of the lesion for 14 days
Category
Treatment - Drugs
2
Description
Control group: 40% salicylic acid solution prepared from a pharmacy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sedighe Tahereh hospital
Full name of responsible person
Zabihollah Shahmoradi
Street address
Khorram St., jomhouri-e-Eslami sq., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3335 9933
Fax
+98 31 3337 3733
Email
emrc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciencesو Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Assiciate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Isfahan University of Medical Sciences, Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD