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OpenTrials
Completed

NCT Number: NCT00874094

Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds

Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period.

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Key information

Conditions

Nasolabial Folds

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite

Chappaqua, New York, 10514, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy adults
  • aged 25- 75 years
  • with moderate to severe nasolabial folds

Exclusion criteria

  • pregnant
  • allergy to local anesthetics
  • history of bleeding disorder
  • active infection at the treatment site
  • injectable filler in the nasolabial folds within past year

Treatment and study plan

Platelet rich fibrin matrix

Biological

0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.

Primary outcomes

  1. Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.

    Time frame: Difference in Measurements taken Pre-treatment and 12 weeks after treatment.

    Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.

Secondary outcomes

  1. Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week

    Time frame: pre-treatment to 1 week after treatment

    Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week

  2. Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks

    Time frame: Pre-treatment to 2 weeks after treatment

    Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks

  3. Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks

    Time frame: Pre-treatment to 6 weeks after treatment

    Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks

Sponsors and collaborators

Lead sponsor

The New York Eye & Ear Infirmary

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 2, 2009
Registry last updated
Jul 12, 2013

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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