Evaluation of the effectiveness of oral isotretinoin on the surgical scars and changes in nasal cartilage in patients with thick skin who have undergone rhinoplasty
Design
Clinical trial with control group, parallel groups, phase 3 on 40 patients, simple randomization method using closed door envelope
Settings and conduct
This clinical trial is done in the Plastic surgery department of Imam Khomeini and Amir Alam Hospitals in Tehran on 40 patients for rhinoplasty with thick skin . Eligible patients are divided into control and intervention groups after obtaining consent, and in intervention group, in addition to routine treatment from 1 week before to two months after surgery, 20 mg isotretinoin tablets are taken orally 3 times a week, which in the control group performs only routine treatments. Finally, the results are entered into SPSS software and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who are candidates for primary rhinoplasty and have thick nasal skin.
Exclusion criteria: absence of allergy to vitamin A, pregnancy decision from one month before taking one year later, breastfeeding, hyperlipidemia and liver and kidney diseases.
Intervention groups
The case group includes patients with thick nasal skin who underwent rhinoplasty and received isotretinoin tablets 20 mg 3 times a week from one week before to two months after the surgery.
The control group includes patients with thick nasal skin who underwent rhinoplasty and did not receive medication.
Main outcome variables
Scars and deformation of cartilage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240204060896N1
Registration date:2024-02-11, 1402/11/22
Registration timing:registered_while_recruiting
Last update:2024-02-11, 1402/11/22
Update count:0
Registration date
2024-02-11, 1402/11/22
Registrant information
Name
Maryam Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 9904
Email address
maryam_nazari1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of oral isotretinoin on the results of rhinoplasty (scar and cartilage shape) in patients with thick nasal skin.
Public title
Effect of isotretinoin on the results of rhinoplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with thick nasal skin
Patients undergo rhinoplasty for the first time
Exclusion criteria:
Allergy to vitamin A
Pregnancy or intention to become pregnant within the next year and breastfeeding (isotretinoin is contraindicated)
Simultaneously suffering from liver, kidney and heart diseases (isotretinoin is contraindicated)
Hyperlipidemia (isotretinoin is contraindicated)
History of rhinoplasty
Skin diseases that change the thickness of the nose, such as rhinophyma
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way using a table of random numbers using www.randomization.com. The numbers will be placed in closed envelopes, and upon entering, participants will be assigned an envelope and will be placed in one of 2 groups.
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
Ethics committee of Tehran University of Medical Science
Street address
Keshavarz Blvd, Ghods St
City
Tehran
Province
Tehran
Postal code
1416633591
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.286
Health conditions studied
1
Description of health condition studied
rhinoplasty
ICD-10 code
M95.0
ICD-10 code description
Acquired deformity of nose
Primary outcomes
1
Description
Scars
Timepoint
1month, 3 months and 6 months after surgery
Method of measurement
The method of variable measurement is qualitative, in the following way, in the follow-up visit after surgery, post-operative photos are taken and compared with preoperative photos by a plastic and reconstructive surgeon.
2
Description
deformation of nasal cartilage
Timepoint
1month, 3 months and 6 months after surgery
Method of measurement
The method of variable measurement is qualitative, in the following way, in the follow-up visit after surgery, post-operative photos are taken and compared with preoperative photos by a plastic and reconstructive surgeon.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, from one week before to two months after surgery patients are treated with 20 mg isotretinoin table 3 times a week and the condition of scar and deformation of the nasal cartilage is evaluated 1, 3 and 6 months after consumption. Isotretinoin manufactured in Iran under the brand name NORMSKIN is used in the study.
Category
Treatment - Other
2
Description
Control group: In this group, routine drugs are prescribed after surgery and isotretinoin is not prescribed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Omid etemad
Street address
End of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
3314114197
Phone
+98 21 6119 0000
Email
maryam_nazari1@yhoo.com
2
Recruitment center
Name of recruitment center
Amir A'lam Hospital
Full name of responsible person
Omid etemad
Street address
North Saadi ST.
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6634 3352
Email
maryam_nazari1@yhoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid etemad
Street address
End of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
3314114197
Phone
+98 21 6119 0000
Email
maryam_nazri1@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Etemad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and reconstructive surgery
Street address
End of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
3314114197
Phone
+98 21 6119 0000
Email
maryam_nazari1@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Etemd
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and reconstructive surgery
Street address
End of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
3314114197
Phone
+98 21 6119 0000
Email
maryam_nzari1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Etemad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and reconstructive surgery
Street address
End of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
3314114197
Phone
+98 21 6119 0000
Email
maryam_nazari1@yahoo.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