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"Efficacy of ENDOLIFT in treatment of horizontal neck lines" "Botulinum toxin in treatment of horizontal neck lines"

Efficacy of ENDOLIFT laser versus Botulinum toxin in Treatment of Horizontal Neck LINES: Randomized Clinical Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160427027636N7
Enrollment
40
Registered
2024-07-10
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-07-22

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: Intervention group: The patients who endolift laser will be used for neck wrinkles. Laser endolift with characteristics (EUFOTON, Via Flavia 23/1 - 34148 Trieste (TS) Italy) with sett

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age range 40 to 65 years Evaluation of wrinkles by a doctor and confirmation of the patient's cosmetic intervention candidate All participants provided oral as well as written informed consent

Exclusion criteria

Exclusion criteria: Pregnancy and breastfeeding Neuromuscular failure Hypersensitivity to Botox or laser infection

Design outcomes

Primary

MeasureTime frame
Modified Global Aesthetic Improvement Scale (GAIS). Timepoint: 3 months after the intervention. Method of measurement: Assessment by the researcher (physician) - Modified Global Aesthetic Improvement Scale (GAIS). Six different levels of aesthetic improvement, ranging from “Very Much Improved” to “Very Much Worse.” Each of these ratings has a corresponding description in the “Description” column, which explains the degree of improvement or worsening in appearance.Here’s a brief summary of the table: Very Much Improved: Optimal cosmetic result from this procedure in this subject Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject Improved: Obvious improvement in appearance from the initial condition No Change: The appearance is essentially the same as the original condition Worse: The appearance is worse than the original condition Much Worse: The appearance is much worse than the original condition Very Much Worse: The appearance is very much worse than the original condition.

Secondary

MeasureTime frame
The Wrinkle and Elastosis. Timepoint: At the beginning of the study, 3 months after the intervention. Method of measurement: Assessment by the researcher (physician) - The Fitzpatrick Wrinkle and Elastosis Scale (FWES) is a clinical tool used to assess the severity of wrinkles. It has been modified over time to improve its reliability and applicability.The Modified Fitzpatrick Wrinkle Scale (MFWS) is a validated measurement tool for nasolabial wrinkle severity assessment. It comprises three main classes and three interclasses, with definitions based on a set of reference photographs and descriptions. The scale has demonstrated good inter- and intra-assessor reliability.The FWES, on the other hand, categorizes wrinkle and elastosis severity into three levels: Mild (1-3): Fine texture changes with subtly accentuated skin lines Moderate (4-6): Distinct papular elastosis (individual papules with yellow translucency under direct lighting) and dyschromia Severe (7-9): Multipapular and confluent elastosis (thickened, yellow and pallid) approaching or consistent with cutis rhomboidalis3These scales are used in clinical settings to assess the effectiveness of treatments for wrinkles and other signs of skin aging. They provide a standardized method for quantifying wrinkle depth and severity, which is crucial for evaluating the efficacy of cosmetic techniques and treatments.;Wrinkles. Timepoint: Assessment by the researcher (physician). Method of measurement: Assessment by the researcher (physician) - 5-point wrinkle grading scale - The Score column lists numbers from 0 to 4, each representing a different level of wrinkle severity. The Description column provides details for each score: Score 0 (none): “No wrinkles.” Score 1 (mild): “Fine wrinkles; continuous skin line.” Score 2 (moderate): “Visible wrinkles and slight indentation.” Score 3 (severe): “Clearly visible wrinkles.” Score 4 (extreme): “Deep and furrowed wrinkles” and also includes the phrase “Extremely deep and lon

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Malekan

Mazandaran University of Medical Sciences

malekan.mohammad78@gmail.com+98 911 755 4873

Outcome results

None listed

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