Evaluation of efficacy and safety of Exicilia topical serum(Bimatoprost 0.03) for improvement of eyebrow hypotrichosis
Design
This is a phase II, single arm, before after,study with 22 sample size. The study is not blinded and randomized.
Settings and conduct
The study will be performed in center for research and training in skin Diseases & Leprosy. 22 volunteers will be enrolled to the study after signing consent form.Volunteers will be used topical Exicilia serum (containing 0.03% bimatoprost) for 16 weeks and then will be evaluated clinically by a dermatologist according to GEBA scoring and trichoscan measurement.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged between 18 to 60 years, eyebrow hypotrichosis in grade 1 or 2 (GEBA Score), Signing consent form
Exclusion criteria:Having alopecia areata, permanent tattoos, moles, scars or any damage to the eyebrows that interferes with assessments, fillers injection in the eyebrow area in the past year, eyebrow extensions in the last 3 months, pregnancy and lactation
Intervention groups
intervention group: 16 weeks treatment with topical Exicilia serum (containing 0.03% bimatoprost) manufactured by Cinagen company, once daily
Main outcome variables
Percentage of people with one grade or more improvement in GEBA scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N9
Registration date:2020-08-24, 1399/06/03
Registration timing:registered_while_recruiting
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of Exicilia topical serum(bimatoprost 0.03) for improvement of eyebrow hypotrichosis
Public title
Evaluation of efficacy of Exicilia topical serum in eyebrow hypotrichosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18 to 60 years
eyebrow hypotrichosis grade 1 or 2 according to GEBA Scoring
Signing consent form
Exclusion criteria:
Having alopecia areata
Permanent tattoos, moles, scars or any damage to the eyebrows that interferes with assessments
fillers injection in the eyebrow area in the past year
Eyebrow extensions in the last 3 months
Pregnancy and lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-08-04, 1399/05/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.279
Health conditions studied
1
Description of health condition studied
hypotrichosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people with one grade or more improvement in GEBA scale
Timepoint
Before intervention and 8 and 16 weeks after intervention.
Method of measurement
Scoring eyebrow thickness using digital photos based on Allergan Global Eyebrow assessment (GEBA)
Secondary outcomes
1
Description
Patient satisfaction from treatment
Timepoint
16 and 24 weeks after intervention
Method of measurement
Using a 6-point Likert scale
2
Description
Comparison of eyebrow hair count
Timepoint
Before intervention and 16 and 24 weeks after intervention
Method of measurement
Trichoscan
Intervention groups
1
Description
Intervention group: 16 weeks treatment using topical Exicilia serum (containing 0.03% bimatoprost) manufactured by CinnaGen company, once daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in Skin Diseases & Leprosy Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Street address
No 415- Taleghani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 8190
Email
dermalab@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CinnaGen Co.
Full name of responsible person
Hale Hamedifar
Street address
No.2 , 7thSt., Simaye Iran St., Shahrak Gharb
City
Tehran
Province
Tehran
Postal code
1467635165
Phone
+98 21 4291 5000
Email
cinnagen@cinnagen.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CinnaGen Co.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
lab manager
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 415, Taleqani avenue.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 8190
Email
aniseh_samadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Dermatologist
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No 415, Taleqani avenue.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 8190
Email
crtsdl_head@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
clinical trials
Street address
No 415, Taleqani avenue.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 8190
Email
ahmadi.maryam648@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available