Comparison of the effect of 5% formalin solution and anti-wart lotion (combination of salicylic acid 16.7% and lactic acid 16.7% in flexible collodion) in the treatment of wart
Comparison of the effect of Formalin 5% solution and Anti-wart lotion (salicylic acid 16.7% and lactic acid 16.7%) in the treatment of wart
Design
Clinical trial with parallel, randomized groups; Phase 3 trial; on 60 people who went to the dermatology clinic of Imam Khomeini Hospital in Ahwaz.
Settings and conduct
The field of the study: Dermatology clinic of Imam Khomeini Hospital in Ahvaz
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of plantar wart or common wart in the hands and feet.
Exclusion criteria: Patients with a history of formaldehyde allergy; pregnancy or lactation; any treatment of wart in the last two weeks; any severe systemic disease; patients who also have other skin conditions such as lichen planus, psoriasis or eczema in the site of wart lesions; inability to cooperate with topical medications due to young age or sensory impairment.
Intervention groups
Intervention group 1:In formalin group,lesions were soaked with formalin 5% solution in shallow dish for 15-20 minutes twice a day, and if the soaking method was difficult, formalin-soaked cotton was placed on the wart lesions with an adhesive tape for 15-20 minutes.The duration of treatment was 8 weeks and the response to treatment was evaluated every four weeks.
Intervention group 2:In lotion group, patients were treated with anti-wart lotion (containing 16.7% salicylic acid and 16.7% acetic acid) twice a day for 8 consecutive weeks. The solution was applied to the wart lesions by a small brush and then were covered with an adhesive tape for 15-20 minutes. The treatment lasted 8 weeks and the response to treatment was evaluated every four weeks
Main outcome variables
Warts count change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200530047603N1
Registration date:2020-06-22, 1399/04/02
Registration timing:retrospective
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Simin Mansorian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 1837
Email address
mansorian_s@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-12, 1398/04/21
Expected recruitment end date
2019-11-30, 1398/09/09
Actual recruitment start date
2019-07-12, 1398/04/21
Actual recruitment end date
2019-11-30, 1398/09/09
Trial completion date
2020-03-09, 1398/12/19
Scientific title
Comparison of the effect of 5% formalin solution and anti-wart lotion (combination of salicylic acid 16.7% and lactic acid 16.7% in flexible collodion) in the treatment of wart
Public title
The effect of formalin in the treatment of wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of plantar wart and common wart in the hands and feet
Exclusion criteria:
Patients with a history of formaldehyde allergy
Immunodeficiency
Severe dermatitis
Diabetes
Pregnancy or lactation
History of respiratory illnesses such as asthma
Any treatment for wart in the last two weeks
Taking immunosuppressive drugs
Any severe systemic disease
Patients with peripheral vascular disorder
Patients with peripheral neuropathy
Patients who also have other skin conditions such as lichen planus, psoriasis or eczema in the site of wart lesions
Inability to cooperate in using topical drugs due to young age or sensory impairment
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are divided into two groups based on the block randomization method. Blocks of size 4 have been used for this purpose. A random sequence based on this method has been extracted from Sealedenvelope.com.
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 Ahvaz University of Medical Sciences
Street address
Vice Chancellor for Research; Ahvaz Jundishapur University of Medical Sciences; Golestan boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Approval date
2019-07-12, 1398/04/21
Ethics committee reference number
IR.AJUMS.REC.1398.287
Health conditions studied
1
Description of health condition studied
Wart
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Wart count change
Timepoint
Before intervention and then every 4 weeks during intervention and three months after the end of the treatment
Method of measurement
By counting wart number
Secondary outcomes
1
Description
Dryness
Timepoint
Every 4 weeks during intervention
Method of measurement
Questionnaire
2
Description
Erythema
Timepoint
Every 4 weeks during intervention
Method of measurement
Questionnaire
3
Description
Fissuring
Timepoint
Every 4 weeks during intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: In formalin group, lesions were soaked with formalin 5% solution in shallow dish for 15-20 minutes twice a day, and if the soaking method was difficult, formalin-soaked cotton was placed on the wart lesions with an adhesive tape for 15-20 minutes.The duration of treatment was 8 weeks and the response to treatment was evaluated every four weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: In lotion group, after rubbing vaseline on the healthy skin around the wart lesions , patients applied the anti-wart lotion with a small brush to the lesions and then covered them with an adhesive tape for 15- 20 minutes.The duration of treatment was 8 weeks and the response to treatment was evaluated every four weeks.