Evaluation the effectiveness of topical isotretinoin on the satisfaction of patients with thick and oily skin who have undergone rhinoplasty
Design
Clinical trial with control group, parallel groups, double-blind, phase 3 on 40 patients, simple randomization method using closed door envelope
Settings and conduct
This double blind clinical trial (participants in the study and analyzers are blinded) is done in the ENT department of Ghaem Hospital in Mashhad on 40 patients for rhinoplasty with thick and oily skin . Eligible patients are divided into control and intervention groups after obtaining consent, and in intervention group, in addition to routine treatment one month after surgery, they take 0.05% isotretinoin gel topically every night, which in the control group performs only routine treatments. Finally, the results are entered into SPSS software and analyzed.
Participants/Inclusion and exclusion criteria
Candidates for rhinoplasty who do not have a history of skin allergies and do not decide to become pregnant from one month before use to one month after use and not being in Breastfeeding period.
Intervention groups
Patients with thick and oily skin diagnosed by a dermatologist and if they have inclusion criteria who underwent rhinoplasty surgery,Examined and photographed and after obtaining a whole history and completing the Demographics information form they are selected. In the control group, routine treatment recommendations is performed and in the intervention group, in addition to routine recommendations, one month after surgery, 0.05% isotretinoin gel (every night) is prescribed for 6 months.
Main outcome variables
Nasal edema and ecchymosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180217038763N3
Registration date:2021-10-02, 1400/07/10
Registration timing:prospective
Last update:2021-10-02, 1400/07/10
Update count:0
Registration date
2021-10-02, 1400/07/10
Registrant information
Name
mehdi bakhshaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3492
Email address
mehbakhsh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of topical isotretinoin after rhinoplasty in people with thick and oily skin of the nose
Public title
Evaluation the effectiveness of isotretinoin in people with rhinoplasty with thick and oily skin
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for rhinoplasty who have thick and oily skin of the nose
Conscious consent to participate in the study
Exclusion criteria:
Use of other medications in addition to prescribed medications
Decide to get pregnant from one month before starting to one month after finishing
Breastfeeding
Dry and sensitive skin
Incidence of skin allergies
Use of drugs which have been shown to interact with isotretinoin
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects and those evaluating the outcome will be unaware of the intervention and control groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.036
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
Edema and nasal ecchymosis
Timepoint
1month, 3 months and 6 months after surgery
Method of measurement
By an ENT specialist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, in addition to routine treatment, 1 month after surgery patients are treated with 0.05% isotretinoin gel (every night) and the condition of nasal edema is evaluated 1, 3 and 6 months after consumption.
Category
Treatment - Other
2
Description
Control group: In this group, routine recommendations include using oil-free sunscreen and skin trauma care and seeing a doctor in case of any side effects.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mehdi Bakhshaee
Street address
بیمارستان قائم خیابان احمد اباد
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
bakhshaeem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Morteza Noorollahian Mohajer
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
Noorollahianm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Morteza Noorollahian Mohajer
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
Noorollahianm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Morteza Noorollahian Mohajer
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
Noorollahianm@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available