NCT06179082

Brief Summary

The main objective of this study is to analyze the efficacy and safety of PDO threads in correcting deep static wrinkles on the upper face.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

December 19, 2023

Last Update Submit

December 24, 2023

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (2)

  • improvement in wrinkles

    a Global Aesthetic Improvement Scale (GAIS) as follows: 1: no change; 2: improved; 3: much improved; 4: very much improved.

    2 months after the procedure

  • patient satisfaction

    using the following scale: excellent, very good, good, fair

    2 months after the procedure

Study Arms (2)

Group A

ACTIVE COMPARATOR

received Botox then threads

Combination Product: Botox then threads

Group B

ACTIVE COMPARATOR

received threads insertion only

Procedure: threads only

Interventions

Botox then threadsCOMBINATION_PRODUCT

patients in which Botox injection then threads insertion were used

Group A
threads onlyPROCEDURE

patients in which threads insertion only was used

Group B

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult females and males between 30 and 65 years of age seeking treatment for static wrinkles on forehead.

You may not qualify if:

  • Patients who received filler injection within a period of 12 months before thread insertion and during the follow-up period.
  • Patients with a history of plastic surgery on the face.
  • Visible scars that may affect evaluation of a response and/or quality of photography and previous botulinum toxin treatment within the prior 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig university hospitals

Zagazig, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2023

First Posted

December 21, 2023

Study Start

February 1, 2023

Primary Completion

October 1, 2023

Study Completion

November 15, 2023

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

EG(1)