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Completed

NCT Number: NCT01775293

Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh

The aim of this study is to evaluate the efficacy and safety of the investigational device, RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.

Study hypothesis

* level of significance: alpha=0.05( two-side) * power of test: (power= 1-beta),power=0.08 * H0: P equals P0 * H1: P unequals P0 * The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)

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Key information

Conditions

Nasolabial Fold

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, Seongbukgu/Seoul, 136-705, South Korea

About this study

  • Benefits
  • enhancing self-satisfaction and quality of life by improving skin elasticity and correcting folds in the nasolabial fold area 2. Risks
  • erythema, swelling, pain and redness in the facial area generally resolve in 1 week 3.Duration of study
  • entire duration: approximate 36weeks
  • Follow-up period: 7 weeks
  • Enrollment period: 12 weeks 4. study design
  • 2 step operation process
  • First step- insert polypropylene mesh under the skin
  • Second step- pull the polypropylene mesh 3 weeks later

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who had soft tissue sagging around nasolabial fold
  • Female aged between 30 and 65, having grade 3 or 4 of nasolabial fold as Wrinkle severity Rating Scale(WSRS)
  • Subjects who voluntary decided to participate in the study and signed the informed consent

Exclusion criteria

  • Subjects who have a skin disease on the face
  • Subjects who have severe facial skin disease
  • Subjects who are constantly taking anti-coagulants including aspirin
  • Subjects who have too thin or thick skin
  • Subjects who have a systemic disease such as uncontrolled high blood pressure, diabetes, heart disease
  • Subjects who had an allergy to non-absorbable material.
  • Subjects who are taking immune suppressants
  • General weakness status
  • Pregnant or lactating women
  • Subjects who have an asthma, cancer, AIDS, Cystic fibrosis, Immobility cilia syndrome, leukopenia, Immunoglobulin deficiency, active infectious disease, serious liver or renal disease,
  • Subjects who had a history of dermal augmentation surgery with permanent implants(e.g. silicone, Softform®)on the face
  • Subjects who participated in other clinical trial within 30 days from screening

Treatment and study plan

Non-absorbable polypropylene mesh

Device

2 step procedures

  • first step is insertion of Non-absorbable polypropylene mesh under the facial skin
  • second step is pulling of Non-absorbable polypropylene mesh after 3 weeks of 1 step

Primary outcomes

  1. The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration

    Time frame: change in the WSRS from baseline at7 week

    The efficacy is assessed by the severity of the fold determined by the WSRS assessed by the investigator with photos WSRS(Wrinkle Severity Rating Scale)is be evaluated from 1 to 5 according to the severity of wrinkles

    (1= no visible fold, 5= extremely deep and long fold)

Secondary outcomes

  1. The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration

    Time frame: Changes Satisfaction from baseline at 7week

    The changes in the satisfaction(VAS-visual analog scale) of the pre and post rhytidectomy from baseline at 7week after administration VAS(visual analog scale)is to be evaluated from 0 to 100 by the participant ( 0= no wrinkle, 100= severe wrinkle)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • D.med

Registry information

Official study title

A Multi Center, Non-comparative Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety After Rhytidectomy Using Non-absorbable Mesh(RPM)

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 24, 2013
Registry last updated
Jan 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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