Background and objectives: Considering prevalence of alopecia areata and its complications, failure of treatment and unknown pathogenesis of this illness, a comparative study took place by using topical minoxidil 2% and topical rosemary solution for treatment of this disease.
Materials and method: patients with alopecia areata were divided into 4 groups by random permutation, each group contained 50 patients. Group 1 received combination of topical minoxidil 2% and topical rosemary, group 2 received only topical minoxidil 2% solution, group 3 received only topical rosemary solution and 4th group was control group, where the patients did not received any treatment and just rubbed the site of disease for the same period of time. The patients were under observation for one year.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061618116N1
Registration date:2014-07-03, 1393/04/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-03, 1393/04/12
Registrant information
Name
Mahshid Ghodrat
Name of organization / entity
Fasa University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 71 1624 5127
Email address
m.ghodrat@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Fasa University of Medical Scienses
Expected recruitment start date
2012-03-05, 1390/12/15
Expected recruitment end date
2013-03-06, 1391/12/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of topical minoxidil in comparison with topical minoxidil plus topical rosemary on treatment of alopecia areata
Public title
Therapeutic effects of topical rosemary on treatment of alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patient has alopecia areata; disease duration less than 6 months.
Exclusion criteria: the patient has another sort of alopecia such as fungal disease; special illnesses such as malignancy and cancer.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
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
Fasa University of Medical Scienses
Street address
Fasa University of Medical Scienses, Ebne Sina square
City
fasa
Postal code
Approval date
2012-03-04, 1390/12/14
Ethics committee reference number
e-09202
Health conditions studied
1
Description of health condition studied
Alopecia areata
ICD-10 code
L63
ICD-10 code description
Alopecia areata
Primary outcomes
1
Description
Terminal hair growth
Timepoint
Before study, 1 month after starting the study, monthly during the study, 3 months after study
Method of measurement
Questionnaire, observation
Secondary outcomes
1
Description
Skin dermatitis
Timepoint
1month after starting the study, monthly during the study
Method of measurement
Observation
Intervention groups
1
Description
Minoxidil solution 2% (including 20 mg minoxidil in 1 ml solution of ethylene glycerol and water)twice a day - 8- 10 drop on area measuring about 3- 4 cm . and for better absorption massaging the area for 10 min. dosage of solutions was changeable due to size of area of involvement. after usage avoid washing the area for 2 hours
Category
Treatment - Drugs
2
Description
Rosemary solution(including 3.7 mg sineolin 1 ml solution of aqua and jojoba oil and grapes oil) twice a day - 8- 10 drop on area measuring about 3- 4 cm . and for better absorption massaging the area for 10 min. dosage of solutions was changeable due to size of area of involvement. after usage avoid washing the area for 2 hours
Category
Treatment - Drugs
3
Description
Combination of rosemary solution and minoxidil 2% solution minoxidil solution 2% (including 20 mg minoxidil in 1 ml solution of ethylene glycerol and water) rosemary solution(including 3.7 mg sineolin 1 ml solution of aqua and jojoba oil and grapes oiltwice a day - 8- 10 drop on area measuring about 3- 4 cm . and for better absorption massaging the area for 10 min. dosage of solutions was changeable due to size of area of involvement. after usage avoid washing the area for 2 hours
Category
Treatment - Drugs
4
Description
Control group: massaging the involved area twice a day for 10 min without using any medfication on site of disease.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fasa Hamze clinic
Full name of responsible person
Ghorbanali Bordbar
Street address
Mahdie street- Phase 3- Fasa
City
Fasa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Scienses
Full name of responsible person
Ehsan Bahramali
Street address
fasa university of medical sciences deputy of research-ebne sina square-fasa
City
Fasa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?