Abstract
Background and objectives: Alopecia areata is a chronic, inflammatory disease characterized by rapid onset of total hair loss in a sharply defined; usually round area in any hair bearing area. This disease accounts for 0.7 – 3 percent of patients seen by dermatologist. There is no definite treatment for it, therefore the efficacy of minoxidil solution and the combination of this solution with rosemary for treatment of alopecia areata was investigated in this study.
Materials and method: In this clinical trial 1oo patients with alopecia areata referred to Hamzeh polyclinic in Fasa (south of Iran) during 2012-2013, were divided into 2 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 solution for about six months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014073118116N2
Registration date:2014-08-02, 1393/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-02, 1393/05/11
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
2011-12-31, 1390/10/10
Expected recruitment end date
2012-12-31, 1391/10/11
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:
1. The patient has alopecia areata regardless of the site of disease.
2. The patient’s duration of disease is less than 1 year.
3. The patient is from Fars province in Iran.
Exclusion criteria:
1. The patient has other kinds of alopecia rather than alopecia areata
such as: alopecia induced by chemotherapy, tinea capitis and fungal
diseases, trichotillomania and etc.
2. The patient has alopecia universalis.
3. The patient has special diseases such as cancer.
4. The patients with open wound or scar and loss of integrity of skin in the site of the disease
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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 deputy of research
Street address
Fasa University of Medical Scienses, Ebne Sina square,fasa,fars,iran
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
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
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Fasa Hamzeh clinic
Full name of responsible person
Ghorbanali Bordbar
Street address
hamzeh clinic-mahdie street- Fasa-iran
City
Fasa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
fasa university of medical sciences deputy of research
Full name of responsible person
Dr Ehsan Bahramalid
Street address
Iran-Fars-Fasa_ebne sina square-fasa university of medical sciences deputy of research
City
Fasa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
fasa university of medical sciences deputy of research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Fasa University of Medical Scienses
Full name of responsible person
Mahshid Ghodrat
Position
General practitioner
Other areas of specialty/work
Street address
School of Medicine, Fasa University of Medical Scienses
City
Shiraz
Postal code
Phone
+98 71 1624 5127
Fax
Email
m.ghodrat@fums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
fasa university of medical scienses -dermatology ward
Full name of responsible person
Mohammad Hassan Lohrasb
Position
Dermatologist
Other areas of specialty/work
Street address
valiasr hospita-ebnesina square-Fasa
City
Fasa
Postal code
Phone
00
Fax
Email
m.lohrasb@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Scienses
Full name of responsible person
Mahshid Ghodrat
Position
General practitioner
Other areas of specialty/work
Street address
School of Medicine, Fasa University of Medical Scienses
City
Shiraz
Postal code
7188633515
Phone
+98 71 1624 5127
Fax
Email
m.ghodrat@fums.ac.ir; mahshid.ghodrat@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)