The aim of this study was to evaluate the effect of lotion produced in comparison with placebo lotion in reducing dry skin on the hands of patients undergoing peritoneal dialysis.
Design
Patients before treatment and one month later using a hand skin stereomicroscope with a magnification of 3 in terms of visual scoring of skin scale (VSS) which is evaluated to determine the amount of skin moisture and overall skin damage.
Also, using the hand skin assessment form, the patient evaluates 4 variables including appearance, intactness moisture and itching or burning sensation by the patient with criteria (1-7) for each index.
Settings and conduct
Patients before treatment and one month later using a hand skin stereomicroscope with magnification*3 in terms of visual scoring of skin scale (VSS) which is evaluated to determine the amount of skin moisture and overall skin damage.
Participants/Inclusion and exclusion criteria
Entry conditions: presence of dry skin in dialysis patients
Conditions of non-entry: no itching on the skin of the dialysis patient and unwillingness to participate in the trial
Intervention groups
Uric patients treated with peritoneal dialysis who have dry skin are randomly divided into two groups: 1- lotion and 2- placebo (lotion without ammonium lactate)
The results before and after the intervention are evaluated in case and control groups.
Main outcome variables
The system has 6 degrees that are rated by the researcher from the number of normal skin without skin and skin irritation to degree 0 of skin cracks and extensive red fissures or occasional bleeding.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171009036672N2
Registration date:2022-12-24, 1401/10/03
Registration timing:retrospective
Last update:2022-12-24, 1401/10/03
Update count:0
Registration date
2022-12-24, 1401/10/03
Registrant information
Name
omid rajabi
Name of organization / entity
university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 3483
Email address
rajabio@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2022-04-18, 1401/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and Evaluation of the Moisturizing Effect of Ammonium Lactate 12% Lotion on Dermatological Disease of the Uremic Patients
Public title
Moisturizing effect of 12% ammonium lactate lotion in the treatment of dry skin in dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Uric patient treated with peritoneal dialysis
Existence of dry skin
Exclusion criteria:
History of sensitivity to any of the components of the product
Reluctance to participate or continue the plan
Existence of skin diseases except dryness
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
A double-blind randomized comparative clinical trial was conducted to investigate the effectiveness of ammonium lactate 12% against placebo lotion without medicinal substance. A study in the form of a questionnaire design related to the complications of uremic itching and the effect of 12% ammonium lactate lotion, which was provided to the participants and was filled again four weeks later by them to compare the effect of the lotion.
The randomization method was done in a simple way and randomly in two groups.
The randomization unit was checked individually in two different groups.
The randomization tool was filled in the form of a hand skin evaluation questionnaire (expression of uremic itching side effects) before and after using the drug and for four weeks. Finally, using statistical software, the percentage of patients' satisfaction with the drug was evaluated.
The way of constructing the random sequence was that the patients were randomly selected in two different groups
Concealment was done in such a way that the patients did not know about the use of drugs or placebos, and drug distribution was done by the researcher . In this way, the first group used the drug (ammonium lactate 12%) and the second group used a placebo, i.e. a 50% w/w paraffin emulsion in water.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding was done in such a way that the participants, the ward nurse and the clinical supervisor were not aware of the drug or placebo, and the drug distribution was done by the researcher. Also, the person evaluating the outcome and the person analyzing the data did not know how to distribute the drug and placebo among the patients. In this way, the first group of participants used the drug (ammonium lactate 12%) in one day without knowing the name, and the second group used a placebo, i.e. 50% w/w paraffin emulsion in water.
Patients were randomly selected according to uremic pruritus problems: the first group used medicine and the second group used placebo
In this double-blind study, patients in both groups are evaluated before treatment and one month after using a hand skin stereomicroscope with 3x magnification in terms of visual scoring to determine the level of skin moisture and overall skin damage. This system has 6 grades, from 6 (normal skin without crusting and skin irritation) to 0 (skin cracks and wide fissures, redness or occasional bleeding) by the researcher and the ward nurse.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Mashhad university of Medical Sciences Research
Street address
Research and Technology Vice-Chancellor, next to Hoize Cinema, Qurashi Building, Mashhad, University St.
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.MUMS.PHARMACY.REC.1398.027
Health conditions studied
1
Description of health condition studied
Severe dry skin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining skin moisture
Timepoint
Before starting treatment and 3 days after taking the drug for a month
Method of measurement
The system has 6 degrees, from a score of 6 normal skin without scales ﴾to 0 degrees﴿ skin cracks
2
Description
General skin damage
Timepoint
Before starting treatment and 3 days after taking the drug for a month
Method of measurement
The system has 6 degrees, from a score of 6 normal skin without scales ﴾to 0 degrees﴿ extensive fissures redness or occasional bleeding
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The effectiveness of ammonium lactate 12% was investigated. A study in the form of a questionnaire design related to the complications of uremic itching and the effect of the drug, which was given to the participants and filled again four weeks later by them to compare the effect of the lotion.
Category
Treatment - Drugs
2
Description
control group: Placebo, lotion, placebo without medicinal substance, a study in the form of a questionnaire design related to the effects of uremic itching and the effect of the placebo, which was given to the participants and filled again four weeks later by them to compare the effect of the lotion.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital of Mashhad
Full name of responsible person
omid rajabi
Street address
faculty of pharmacy, ferdowsi university of mashhad, park sq.,montazeri blv.
City
mashhad
Province
Razavi Khorasan
Postal code
9188617871
Phone
+98 51 3180 1126
Fax
+98 51 3884 3483
Email
rajabio@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research and Technology Mashhad University of Medical Sciences
Full name of responsible person
majid ghayour mobarhan
Street address
Research and Technology Vice-Chancellorو next to Hoize Cinema, Qurashi Building, Mashhad, University St.
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research and Technology Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
atoosa haghighizadeh
Position
postdoc
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
pharmacy school, ferdowsi university of mashhad, park sq., montazer blv.
City
mashhad
Province
Razavi Khorasan
Postal code
9188617871
Phone
+98 51 3180 1126
Fax
+98 51 3884 3483
Email
atoosa.hz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
omid rajabi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
pharmacy school, ferdowsi university of mashhad, park sq., montazeri blv.
City
mashhad
Province
Razavi Khorasan
Postal code
9188617871
Phone
+98 51 3180 1126
Fax
+98 51 3884 3483
Email
rajabio@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
yohana seyed hosseini
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
pharmacy school, ferdowsi university of mashhad, park sq., montazeri blv.
City
mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1126
Email
yohanna.hosseini73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
How to improve patients can be presented in the form of a table
When the data will become available and for how long
Access period starts from the summer of 1401 for 6 months
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Available for medical purposes and through a doctor
From where data/document is obtainable
emails
What processes are involved for a request to access data/document