Evaluation of efficacy and safety of diphencyprone treatment on alopecia areata of eyebrows of patients referred to Tehran Razi hospital`s diphencyprone clinics in year 1394
Summary: Despite effective treatment results of diphencyprone treatment for scalp alopecia areata, very few studies have evaluated its results for eyebrow area. Therefore, designing a study to evaluate the therapeutic efficacy and side effects of diphencyprone on the eyebrow could be useful. In this clinical trial, the study population are patients referring to diphencyprone clinic of Razi dermatology hospital at Tehran University of medical sciences. Treatment of the left or right eyebrow will be started randomly and the other eyebrow would be untreated as control. After favorable response, the treatment will be continued on both sides.
Patients with bilateral eyebrow involvement will be enrolled in the study. Those who have received treatment on eyebrows in the past three months, or with a history of vitiligo will be excluded. A sample size of 40 is estimated. Intervention of this study is diphencyprone application on eyebrow weekly for 6 months.
Before treatment, and after three and six months of treatment, imaging of both eyebrow will be performed. Regrowth of hair will be compared between two eyebrows with and without active treatment. By comparing the changes in alopetic region of eyebrow before and after treatment on images in the semi-quantitative manner, therapeutic effects of diphencyprone used in the eyebrow area will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061520250N1
Registration date:2015-11-17, 1394/08/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-17, 1394/08/26
Registrant information
Name
Narges Ghandi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
nghandi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research and technology,Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2015-11-09, 1394/08/18
Expected recruitment end date
2017-01-10, 1395/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of diphencyprone treatment on alopecia areata of eyebrows of patients referred to Tehran Razi hospital`s diphencyprone clinics in year 1394
Public title
Diphencyprone effect on alopecia areata of eyebrow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 12 to 65 , bilateral eyebrows involvement, the patient's consent to participate in research projects
Exclusion criteria: systemic or topical steroid treatment /immunosuppressive therapy (azathioprine , mycophenolate mofetil) and diphencyprone treatment for eyebrows in the past three months, a personal or a family history of vitiligo, history of Koebner positive dermatoses such as psoriasis, pregnancy or lactation, history of liver/kidney/thyroid disease
Age
From 12 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran University of Medical Sciences Ethics committee
Street address
Tehran University of Medical Sciences, Office of Vice Chancellor for Research and Technology, 6th floor, Ghods Street, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2015-08-10, 1394/05/19
Ethics committee reference number
ir.tums.rec.1394.550
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 regrowth
Timepoint
Third and sixth months after intervention
Method of measurement
Eyebrow regrowth percentage by comparing patients images
Secondary outcomes
1
Description
Patient satisfaction following treatment
Timepoint
Third and sixth months after intervention
Method of measurement
Visual analogue scale
2
Description
Treatment complications
Timepoint
Every two weeks ( 24 times during the study )
Method of measurement
History taking and physical examination
Intervention groups
1
Description
The intervention in this study is topical application of diphencyprone solution on eyebrow by patients. Solution dosage will be determined by a dermatologist. Treatment will be started at 0.0001%-0.001% concentration and after serial examination and history taking it will be increased biweekly as follows: 0.01%, 0.1%, 0.2%, 0.5%, 1% and 2%. The solution will be applied weekly on one eyebrow for six months. Intervention is unilateral for randomly selected side and the other side would be the control. After terminal hair regrowth application would be bilateral. Before and at third and sixth months of treatment, photography of eyebrows would be performed. Different concentrations that mentioned above will be made of diphencyprone powder (product of Sigma Aldrich Company) in acetone base at Razi hospital`s synthetic drugs ward.