Determination and comparison of the effect of Oxybutynin in two forms of gel and nanoemulgel versus placebo in people with primary palmar hyperhidrosis
Evaluation of the local effect of Oxybutynin in two forms of gel and nanoemulgel in treatment of primary palmar hyperhidrosis
Design
Phase 3, parallel group, clinical trial, with consecutive sampling, including 30 patients, double blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in dermatology clinic of Shiraz University of Medical Sciences. Patients are devided into two groups A and B. (each group has 15 members) In group A, patients are randomly assigned to be treated with 1% topical Oxybutynin gel on one side and placebo on the other. In group B, patients are randomly assigned to be treated with 1% topical Oxybutynin nanoemulgel on one side and placebo on the other. All drugs are packed in similar tubes. Topical medications are applied twice daily for a month. Patients are assessed once at the beginning of the study and one time after one month of applying medications and will complete questionnaire related to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Older than 18 years of age patients with primary palmar hyperhidrosis
Exclusion criteria: Using any topical drugs that can affect palmar hyperhidrosis since one month before beginning of the research, Butox injection 3 month before beginning of the research, Pregnancy, Lactation, Hypersensitivity to the research drug
Intervention groups
Intervention group: Oxybutynin gel or nanoemulgel is applied twice daily on the palmar surface of one hand
Control group: Gel base as the placebo on the palmar surface of the other hand
Main outcome variables
hyperhidrosis Disease Severity Scale(HDSS)
Dermatology Life Quality Index(DLQI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210822052255N1
Registration date:2021-09-28, 1400/07/06
Registration timing:registered_while_recruiting
Last update:2021-09-28, 1400/07/06
Update count:0
Registration date
2021-09-28, 1400/07/06
Registrant information
Name
Najmeh Shakouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 3937
Email address
shakouri.negin92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination and comparison of the effect of Oxybutynin in two forms of gel and nanoemulgel versus placebo in people with primary palmar hyperhidrosis
Public title
Evaluation of local effect of Oxybutynin in treatment of palmar hyperhidrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Older than 18 years of age patients with primary palmar hyperhidrosis
Patients should have ability to understand Persian language of written consent and questionnaire to participate in the study
All topical and oral treatments should be discontinued for at least 4 weeks before beginning of the study, except for Botox injections, which should not have been injected in the past 12 weeks.
Exclusion criteria:
Reluctance to cooperate
Hypersensitivity to topical Oxybutynin
Pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
One sample containing the Oxybutynin gel and the other sample containing gel base as the placebo.
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used for the two intervention groups and simple randomization method was used to choose the drug and placebo (left and right hand in each patient). A randomization table has been used for this purpose. The randomization table is attached to the proposal.
Intergroup comparison between two intervention groups and intragroup comparison between each comparison group with its control group will be done. The advantage of using control group in each sample (intragroup comparison) in addition to reducing the sample size, is eliminating intergroup changes and thus increasing the accuracy of the comparison.
Blinding (investigator's opinion)
Double blinded
Blinding description
The tubes containing Oxybutynin gel and placebo are identical and coded. The tubes allocated to each patient are labelled with the same patients of patient recruitment number. Care providor and investigator that deliver the gels are not involved in the outcome assessment. Type of drugs and which hand is being treated and which one is selected as the control remains unclear for both the patient and the outcome assessor until the end of the study. Therefore the research will be double-blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of medical science, Zand Ave.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2021-06-30, 1400/04/09
Ethics committee reference number
IR.SUMS.MED.REC.1400.195
Health conditions studied
1
Description of health condition studied
Primary palmar hyperhidrosis
ICD-10 code
L74.512
ICD-10 code description
Primary focal hyperhidrosis, palms
Primary outcomes
1
Description
Hyperhidrosis Disease Severity Index (HDSS)
Timepoint
Before intervention and one month after starting intervention
Method of measurement
Hyperhidrosis Disease Severity Index (HDSS) score formula
Secondary outcomes
1
Description
Dermatology Life Quality Index (DLQI)
Timepoint
Before intervention and one month after starting intervention
Method of measurement
Dermatology Life Quality Index (DLQI) formula score
Intervention groups
1
Description
Intervention group1: Simple 1% Oxybutynin gel is applied twice a day on the palm of a patient's hand for a month. Once at the beginning of the study and also after one month of taking the drug, the patient is visited. The drug is made by Dr. ُShohreh Alipour, a Pharmacologist colleague, PhD of Pharmaceutical Sciences, in the Pharmaceutics Laboratory of School of Pharmacy, Shiraz university of Medical Sciences.
Category
Treatment - Drugs
2
Description
Intervention group2: 1% Oxybutynin nanoemulgel is applied twice a day on the palm of a patient's hand for a month. Once at the beginning of the study and also after one month of taking the drug, the patient is visited. The drug is made by Dr. ُShohreh Alipour, a Pharmacologist colleague, PhD of Pharmaceutical Sciences, in the Pharmaceutics Laboratory of School of Pharmacy, Shiraz university of Medical Sciences.
Category
Treatment - Drugs
3
Description
Control group1: Gel base as the placebo is applied twice a day on the palm of the other patient's hand in both groups for a month. Once at the beginning of the study and also after one month of taking the drug, the patient is visited. The drug is made by Dr. ُShohreh Alipour, a Pharmacologist colleague, PhD of Pharmaceutical Sciences, in the Pharmaceutics Laboratory of School of Pharmacy, Shiraz university of Medical Sciences.