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Evaluation of the effect of botulinum toxin and Profhilo hyaluronic acid injection in rejuvenation of the neck.

Evaluation of the effect of botulinum toxin injection in comparison with botulinum toxin injection and PROFHILO hyaluronic acid in rejuvenation of the neck.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201204049589N1
Enrollment
20
Registered
2021-03-02
Start date
2019-08-23
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Horizontal neck lines.

Interventions

Intervention 1: 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

Sponsors

Tehran University of Medical Sciences
Lead Sponsor
IBSA Institue Biochemique SA
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.;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).;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).;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.;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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsma Jabbari

Tehran University of Medical Sciences

jabbari.asma@gmail.com+98 21 5516 9657

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026