The aim of this study was to study the safety and efficacy of DMA110 topical gel in the treatment of genital wart from Papillomavirus
Design
A phase 1-2 clinical trial with controlled and parallel group, single blind, randomized in 80 patients.
in order to apply the concealment in the randomization process, unique codes will be used on the drug boxes.
Settings and conduct
All patients with genital warts referred to Isfahan University of Medical Sciences clinics (Al-Zahra Hospital and ...) were assigned randomly in 2 groups, receiving DMA110 gel or Pedophilin solution 25% .
Patients are visited weekly for 8 weeks and then once a month for 8 months. The size and number of the lesions and possible side effects of both treatments are recorded Carefully.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with genital warts
Exclusion criteria: Patients who need to take immune suppressive drugs such as corticosteroids , chemotheraputic drugs or undergoing radiation therapy.
Patients suffering from immune deficiency-associated diseases such as diabetes, cancer, HIV.
pregnancy
lactation
A wound or active skin disease other than wart at the treatment site.
Intervention groups
Intervention group: DMA110 topical gel
Control group: Pedophilin solution 25%
Main outcome variables
Side effects
Size of the lesions
Number of the lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181026041466N6
Registration date:2021-05-25, 1400/03/04
Registration timing:registered_while_recruiting
Last update:2021-05-25, 1400/03/04
Update count:0
Registration date
2021-05-25, 1400/03/04
Registrant information
Name
Ali Aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 8149
Email address
ali.aghaei110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical study of safety and efficacy of DMA110 topical gel in the treatment of genital wart from Papillomavirus.
Public title
Clinical study of safety and efficacy of DMA110 topical gel in the treatment of genital wart.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with genital warts
Exclusion criteria:
Patients who need to take immune suppressive drugs such as corticosteroids , chemotheraputic drugs or undergoing radiation therapy.
Patients suffering from immune deficiency-associated diseases such as diabetes, cancer, HIV.
pregnancy
lactation
A wound or active skin disease other than wart at the treatment site
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with quadruple blocks. blocks are produced by use of the online site (www.sealedenvelope.com).
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer will not be aware of the assigned groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2021-04-10, 1400/01/21
Ethics committee reference number
IR.AJUMS.REC.1400.016
Health conditions studied
1
Description of health condition studied
Genital wart
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
Primary outcomes
1
Description
side effects from treatment
Timepoint
In 7, 14, 21, 28, 35, 42, 49, 56, 84, 112, 140, 168, 196 and 238 days.
Method of measurement
Inspection and clinical examination, Patients' complaints.
2
Description
measurement of genital wart size
Timepoint
In 0, 7, 14, 21, 28, 35, 42, 49, 56, 84, 112, 140, 168, 196 and 238 days.
Method of measurement
caliper
3
Description
Number of warts
Timepoint
In 0, 7, 14, 21, 28, 35, 42, 49, 56, 84, 112, 140, 168, 196 and 238 days.
Method of measurement
Clinical counting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: DMA110 Herbal topical gel made by Ryka pharmaceutical co containing Green tea and garlic extract. taking 2-3 times a day on all warts until Complete removal of lesions and Maximum 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: In Control group Pedophilin solution 25% is used once a week by the researcher for the patient up to 6 weeks or until complete clearance. To prevent damage to the healthy tissue of the skin, around the lesions، vaseline cream is used. 4 to 6 hours after application, the skin should be washed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sedighe tahere Hospital
Full name of responsible person
Fariba Iraji
Street address
Khorram street
City
Isfahan
Province
Isfehan
Postal code
814651148
Phone
+98 31 3335 9090
Email
ِDerm@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rayka raya teb co
Full name of responsible person
ali aghaei
Street address
Arak street, Nejatollahi Ave.
City
Tehran
Province
Tehran
Postal code
1598945113
Phone
+98 21 8894 1935
Email
Rykapharmaceuticalco@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rayka raya teb co
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alireza Malayeri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Email
malayeri.a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alireza Malayeri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Email
malayeri.a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alireza Malayeri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy school, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Email
malayeri.a@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Only a part of data will be shared.
When the data will become available and for how long
The access period will be 6 months after the publication of the results.
To whom data/document is available
The information obtained will only be available to researchers working in universities and science centers.
Under which criteria data/document could be used
Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis.
From where data/document is obtainable
Applicants can be contacted with corresponding author by e-mail.
What processes are involved for a request to access data/document
Applicants will be able to access the obtained data from the current study by sending an email to the corresponding author up to one month.