Protocol summary

Study aim
Determining the effectiveness of the combination treatment of topical l-carnitine lotion 1% along with clotrimazole 2% lotion and clotrimazole 2% lotion alone in the treatment of seborrheic dermatitis of the head
Design
Clinical trial with a control group, with parallel groups, 3 blind strains, randomized, phase 2 on 64 patients, a sealed envelope was used for randomization.
Settings and conduct
Patients referred to Al-Zahra hospital clinic with seborrheic dermatitis are divided into 2 groups, one group is treated with combination al-carnitine and clotrimazole and the other group is treated with clotrimazole. The patient, the clinical caregiver and the researcher are not aware of the type of treatment. The clinical pharmacist is responsible for the preparation of these materials during the type of groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from seborrheic dermatitis in the scalp area with clinical diagnosis, no treatment with topical or systemic corticosteroids since four weeks ago, no treatment with methyldopa, chlorpromazine, topical or systemic anti-acne drugs since one month ago, and no systemic disease such as Parkinson's, AIDS and mood disorders Exclusion criteria: history of any drug allergy, lack of consent to participate in the study, failure to visit for follow-up, pregnancy and breastfeeding
Intervention groups
The group treated with a combination of 1% L-carnitine topical lotion and 2% Clotrimazole lotion. The group treated with 2% clotrimazole lotion alone
Main outcome variables
Scalp erythema, peeling, itching; Patient satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150706023081N4
Registration date: 2024-05-20, 1403/02/31
Registration timing: prospective

Last update: 2024-05-20, 1403/02/31
Update count: 0
Registration date
2024-05-20, 1403/02/31
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
iraji@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of combined treatment of topical l-carnitine 1% and clotrimazole 2% with clotrimazole 2% alone, in patients with scalp seborrheic dermatitis
Public title
Comparison of the effectiveness of combined treatment of topical L-carnitine lotion 1% with clotrimazole lotion 2% and clotrimazole lotion 2% alone in the treatment of seborrheic dermatitis of the head (scalp)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having seborrheic dermatitis in the scalp area with clinical diagnosis No treatment with topical or systemic corticosteroids for the previous four weeks No treatment with methyldopa, chlorpromazine, local or systemic anti-acne drugs for one month before Absence of systemic diseases such as Parkinson's, AIDS and mood disorders
Exclusion criteria:
Pregnancy Lack of consent to continue participating in the study Breastfeeding
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple and individual way using a sealed envelope, so that an envelope is randomly removed for each patient, which contains either L-carnitine and clotrimazole treatment group or clotrimazole alone, which is also is a and b.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The only clinical pharmacist is responsible for the preparation of these substances in the current type of groups, the substances are in tubes of the same shape, only the writing is a or b. The appearance of the tubes is also similar.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of medical school of Isfahan University of Medical Sciences
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-12-20, 1402/09/29
Ethics committee reference number
IR.MUI.MED.REC.1402.348

Health conditions studied

1

Description of health condition studied
Seborrheic dermatitis
ICD-10 code
L21.8
ICD-10 code description
Other seborrheic dermatitis

Primary outcomes

1

Description
Scaling
Timepoint
At the beginning of study and 3 months later
Method of measurement
Dermoscopy

2

Description
Scalp erythema
Timepoint
At the beginning of study and 3 months later
Method of measurement
Dermoscopy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Under the combined treatment of L-carnitine and clotrimazole, where the patient uses 1 cc of the solution twice a day in 4 areas, and the duration of the treatment is 4 weeks, the patient before the start of the study, 2 weeks after and 4 weeks after It is evaluated from the beginning of the treatment.
Category
Treatment - Drugs

2

Description
Intervention group: treated with clotrimazole alone, where the patient uses 1 cc of the solution twice a day in 4 areas, and the duration of treatment is 4 weeks, the patient before the study, 2 weeks after and 4 weeks after The initiation of treatment is evaluated.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mehrdad Noroozi
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
7573181746
Phone
+98 31 3822 0000
Email
Alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyyed Hussain bani Hashemi
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3822 0000
Fax
+98 31 3822 0000
Email
Researches@mui.ac.ir
Web page address
Https://Researches.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
Fariba Iraji
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
+98 31 3668 4510
Email
iraji@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
+98 31 3668 4510
Email
iraji@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
+98 31 3668 4510
Email
iraji@med.mui.ac.ir

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data included demographic variables and potential pre- and post-treatment variables after de-identifying shareable subjects.
When the data will become available and for how long
Immediately after publication of literature
To whom data/document is available
Only researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data is accessible only for further understanding
From where data/document is obtainable
It should be requested to the responsible author via email
What processes are involved for a request to access data/document
In order to receive the data, it must be done through the university email, after approval by the responsible author, it will be sent within a week
Comments
Loading...