The purpose of this pilot study is to compare efficacy and side effects of injection of living autologous fibroblast versus TCA 50% for the treatment of atrophic facial scar. The study Population consists of patients with facial contour deformities including acne scars or leishmaniasis scar. A total of 20 patients are randomly assigned into two groups. In one group, the patients receive 3 doses of living autologous fibroblast (20 million/ml) at two weeks interval. In another group, the patients receive 3 times treatment of topical TCA 50%. TCA 50% was applied once monthly for 3 months. Efficacy evaluations are performed every 2 weeks until three months and then 6 and 12 months after the first treatment. The size of scar, patient's satisfaction, and side effects are recorded in each visit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902081159N2
Registration date:2010-10-16, 1389/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-16, 1389/07/24
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of topical TCA %50 and cultured autologous fibroblasts in the treatment of the atrophic scars of face. (Pilot Study)
Public title
Comparative study of topical TCA %50 and cultured autologous fibroblasts in the treatment of the atrophic scars of face.(Pilot Study)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 18 years, dissatisfaction of facial appearance, Negative pregnancy test at the screening visit, signing written informed consent, compliance with the study requirements, Healthy, non-scarred skin for biopsy
Exclusion Criteria: Previous treatment with dermal filler or other method, participating in another clinical trial, History of autoimmune disease or organ transplantation, History of cancer, Active systemic infection, need to chronic antibiotic or steroidal therapy, Using systemic agents that increase bleeding or clotting, any disorder that increase bleeding or clotting, Pregnancy or breast feeding, Known allergic reaction to components of study treatment and/or study injection procedure, Excessive exposure to sun or sunburn in the post-auricular area, Patients with psychological disorders
Age
From 18 years old to 80 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jarib Boulevard, Isfahan, Iran
City
Isfahan
Postal code
Approval date
empty
Ethics committee reference number
4/125763
Health conditions studied
1
Description of health condition studied
atrophic scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Scar size
Timepoint
before and after the intervention
Method of measurement
Photography of scar before beginning of the study and millimeter paper
Secondary outcomes
1
Description
cinical improvement of scar
Timepoint
Before the study and 3, 6, and 12 months after the beginning of study
Method of measurement
Photography of scar at each visit
Intervention groups
1
Description
TCA 50%, topical, once monthly for 3 months.
Category
Treatment - Drugs
2
Description
Autologous fibroblasts (20million/mL), three times with 1-2 weeks intervals
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin Disease and Leishmaniasis Research Center (Sedigheh Tahereh)
Full name of responsible person
Mohamad Ali Nilforoushzadeh
Street address
Skin Diseases and Leishmaniasis Research Center, Third Floor, Sedigheh Tahereh Research Centers, Next to Shahidan Square, Khoram Street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Isfahan University of Medical Sciences
Street address
Hezar Jarib Boulevard, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Skin Disease and Leishmaniasis Research Center (Sedigheh Tahereh)
Full name of responsible person
Dr Mohamad Ali Nilforushzade
Position
Associate Professor of Dermatology,fellowship of laser and skin surgery /Head of Skin Disease and Le
Other areas of specialty/work
Street address
Skin Diseases and Leishmaniasis Research Center, Third Floor, Sedigheh Tahereh Research Centers, Next to Shahidan Square, Khoram Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1337 7767
Fax
Email
Sdlrc@mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin Disease and Leishmaniasis Research Center (Sedigheh Tahereh)
Full name of responsible person
Dr Mohamad Ali Nilforushzade
Position
Associate Professor of Dermatology, Fellowship of laser and skin surgery/ Head of Skin Disease and L
Other areas of specialty/work
Street address
Skin Diseases and Leishmaniasis Research Center, Third Floor, Sedigheh Tahereh Research Centers, Next to Shahidan Square, Khoram Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1337 7767
Fax
Email
Sdlrc@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)