Evaluation of the effect of botulinum toxin injection in comparison with botulinum toxin injection and PROFHILO hyaluronic acid in rejuvenation of the neck.
Comparative study of the effect of Botox injection with a combination of Botox injection and Profilo gel in reducing neck lines
Design
Randomized, parallel group trial with blinded outcome assessment on 20 patients using Block Randomization method and Random Allocation software for randomization.
Settings and conduct
20 patients with neck rejuvenation request in Razi Hospital, Tehran in the first visit receive toxin dysport injection for horizontal neck lines, 2 weeks later 10 patients will be visited again and the first injection of profhilo filler will be performed in horizontal neck lines which will be repeated 1 month later. Paraclinical evaluation will be performed for elasticity , hydration , rate of epidermal water loss and the thickness and density of the dermis and epidermis at the first visit and 6 months after the last injection. physicians evaluating the outcome are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adults over 18 and under 70 with wrinkle severity rating scale between 2-4.
Exclusion criteria: systemic uncontrolled disease, history of fillers or Botox injections in lower face and neck in the past 12 months.
Intervention groups
Control group:10 Participants will be injected with Dysport toxin (IPSEN company) with a total dose of 40 to 70 units in the initial visit.
Intervention group :10 Participants will be injected with Dysport toxin with a total dose of 40 to 70 units at the initial visit. 2 weeks later, these patients will be injected with 2 cc of Profilo gel (IBSA Company), and one month after the first injection of Profilo filler, the second time will be injected with another 2 cc.
Main outcome variables
wrinke severity rating scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201204049589N1
Registration date:2021-03-02, 1399/12/12
Registration timing:registered_while_recruiting
Last update:2021-03-02, 1399/12/12
Update count:0
Registration date
2021-03-02, 1399/12/12
Registrant information
Name
Asma Jabbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 0553
Email address
jabbari.asma@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of botulinum toxin injection in comparison with botulinum toxin injection and PROFHILO hyaluronic acid in rejuvenation of the neck.
Public title
Evaluation of the effect of botulinum toxin and Profhilo hyaluronic acid injection in rejuvenation of the neck.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults over 18 years and under 70 years
Signing a voluntary agreement
WSRS (Wrinkle Severity Rating Scale) between 4 - 2
They do not want to have a surgical procedure
Patients who are not candidates for surgery
Exclusion criteria:
Pregnancy and breastfeeding
Neuromuscular diseases such as myasthenia gravis•
Hypersensitivity to Botox or human albumin•
Uncontrolled systemic disease
Infection, scarring, abnormality at the injection site
History of Botox injection or lower face filler in the last 12 months
Patients treated with aspirin, immunosuppressants, narcotics, antiDepressants and corticosteroids in the last 3 months
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method Using Random Allocation software, 20 patients are assigned to two groups of 10.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, physicians evaluating the outcome without knowing the patient's treatment group, based on a review of pre- and post-treatment photographs compared to the Wrinkle Assessment Scale, record their observational information.
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 Sciences
Street address
Floor 5, Central Building of Tehran University of Medical Science, Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.064
Health conditions studied
1
Description of health condition studied
Horizontal neck lines
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
wrinkle severity rating scale (WSRS)
Timepoint
The first visit and 6 months after Dysport injection and the second time filler
Method of measurement
Score based on the severity of wrinkles by comparing photography and dermoscopy before and after treatment.
Secondary outcomes
1
Description
skin hydration
Timepoint
Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group.
Method of measurement
probe of the MP bolagen multi-adapter device(corporatereg number 5562201656) to measure hydration of the skin
2
Description
skin elasticity
Timepoint
Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group.
Method of measurement
probe of the MP bolagen multi-adapter device(corporatereg number 5562201656)
3
Description
Water loss from the surface of the epidermis
Timepoint
Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group.
Method of measurement
probe of the MP bolagen multi-adapter device(corporatereg number 5562201656)
4
Description
pain during filler injection
Timepoint
During filler injection (two weeks after the first visit and one month after the second visit)
Method of measurement
Patient self-expression form
5
Description
dermis and epidermis density
Timepoint
Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group.
Method of measurement
Neck sonography
6
Description
dermis and epidermis thickness
Timepoint
Baseline visit and 6 months after the second filler injection in one group and one time of receiving dysport in the second group.
Method of measurement
Neck sonography
Intervention groups
1
Description
Control group: In 10 patients, Botulinum toxin (Dysport, IPSEN Company ) injection will be performed in the baseline visit according to the following protocol: 1 vial of Botox Dysport 500 units will be diluted with the addition of 2 and a half cc of normal saline. A 1 ml syringe with a 30 G needle will be used.In horizontal wrinkles, 1 to 2 intradermal injection units are performed at intervals of 1 to 2 cm. The maximum therapeutic dose is 70 units for the whole neck.
Category
Treatment - Drugs
2
Description
Intervention group: In 10 patients, Botulinum toxin (Dysport, IPSEN Company ) injection will be performed in the baseline visit according to the following protocol: 1 vial of Botox Dysport 500 units will be diluted with the addition of 2 and a half cc of normal saline. A 1 ml syringe with a 30 G needle will be used. In horizontal wrinkles, 1 to 2 intradermal injection units are performed at intervals of 1 to 2 cm. The maximum therapeutic dose is 70 units for the whole neck. 2 weeks later, Profhilo gel (IBSA Company) will be injected in these patients. The product is in the form of 2 ml syringes with 29G needle. The injection will be done transversely. 90 degree angle injection or deep platysmal injection should be avoided. The depth of the dermal injection will be deep dermis. The injection will be done at ten points and at each point 2 tenths of a cc. 1 month later, the 10 mentioned patients will receive the second time of Profhilo gel with the same technique.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Asma Jabbari
Street address
Razi Hospital, Vahdat E Eslami Ave, Hafez Ave
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5516 9675
Email
razihospital@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Sahraean
Street address
Qods Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?