Efficacy of rosemary extract lotion in the treatment of dandruff in seborrheic dermatitis in comparison with ketoconazole %2 lotion a double-blind clinical trial
Comparison of the efficacy of rosemary lotion and ketoconazole 2% lotion in the treatment of scalp seborrheic dermatitis
Design
Phase 3, parallel group, clinical trial, with consecutive sampling, including 42 patients, double blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in the dermatology clinic of Shiraz University of Medical Sciences. Group 1 will apply rosemary lotion twice daily on the scalp. Group two will apply ketoconazole 2% lotion twice daily on the scalp. The patients are assessed at the beginning of treatment, first month and 2nd month. The patients and outcome assessor are blinded to the type of treatment.
Participants/Inclusion and exclusion criteria
Patients 18-60 years old clinical diagnosis of scalp seborrheic dermatitis; ASFS score > 10; DLQI index > 2
Intervention groups
Intervention group: Rosemary lotion is applied twice daily on the scalp.
Control group: Ketoconazole 2% lotion is applied twice daily on the scalp.
Main outcome variables
Adherent scalp flaking score ( ASFS score )
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221001056063N1
Registration date:2022-10-11, 1401/07/19
Registration timing:prospective
Last update:2022-10-11, 1401/07/19
Update count:0
Registration date
2022-10-11, 1401/07/19
Registrant information
Name
Fatemeh Alesana
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 1087
Email address
dermatologist2019@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of rosemary extract lotion in the treatment of dandruff in seborrheic dermatitis in comparison with ketoconazole %2 lotion a double-blind clinical trial
Public title
Comparison of the efficacy of rosemary lotion and ketoconazole lotion in treatment of seborrheic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18-60 years old clinical diagnosis of scalp seborrheic dermatitis
ASFS score > 10
DLQI index > 2
Exclusion criteria:
Severe seborrheic dermatitis in other areas
Using antibiotics or immunomodulatory drugs since one month before beginning of the research
Using any topical drugs that can affect seborrheic dermatitis since two weeks before beginning of the research
Using any oral drugs that can affect seborrheic dermatitis since one month before beginning of the research
Other scalp diseases
Scalp surgery in the previous month
Sensitivity to the research drugs
Pregnancy
Lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed by random allocation software and participants are randomly allocated in the intervention or control group. Randomization of 42 participants in the software is performed by randomization blocks with random ratio of 1:1. The output of the software is a table that shows the number of each participant is allocated in the intervention or control group. The medications are in the similar tubes labeled by numbers of the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
All drugs are packed in similar containers and have similar color, smell, and texture; and, the containers allocated to each patient are labelled with the same patients of patient recruitment number. Care provider and investigator that deliver the creams are not involved in the outcome assessment. The outcome assessor is not aware of the type of drugs in each patient. Due to similarity of the drugs and the instructions, the patients are also unaware of the type of used drugs. Therefore the research will be double-blinded.
Placebo
Not 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 Sciences, Zand Ave.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2022-05-22, 1401/03/01
Ethics committee reference number
IR.SUMS.MED.REC.1401.090
Health conditions studied
1
Description of health condition studied
Scalp seborrheic dermatitis
ICD-10 code
L21.9
ICD-10 code description
Seborrheic dermatitis, unspecified
Primary outcomes
1
Description
Adherent scalp flaking score ( ASFS score )
Timepoint
Before intervention and 1 and 2 months after starting intervention
Method of measurement
Adherent scalp flaking score ( ASFS score ) formula
Secondary outcomes
1
Description
Pruritus severity
Timepoint
before intervention and 1 and 2 months after starting intervention