Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02832583
Other study ID # 2014-A00718-39
Secondary ID
Status Completed
Phase N/A
First received July 5, 2016
Last updated September 30, 2016
Start date December 2014
Est. completion date June 2016

Study information

Verified date September 2016
Source Regen Lab SA
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions 4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months after the last injection session. Safety was assessed by reported adverse event analysis.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Patients aged over 40 years with chronological aging

- Completed informed consent form

Exclusion Criteria:

- Pregnancy or breastfeeding

- Patients younger than 40 years

- Use of product or treatment aimed to improve skin rejuvenation over the last six months before study start,

- patients with known hypersensitivity to HA,

- patients with eczema flare-up,

- patients with active skin disorder infection including herpes virus infection, active hepatitis or human infection virus infection.

- Dermatological diseases affecting the face

- Auto-immune disease such as Hashimoto, rheumatoid arthritis.

- Malignancy with or without metastatic disease

- Chemotherapy

- Anticoagulant therapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Regenkit BCT-HA Cellular Matrix
To assess the efficacy of PRP-HA on skin rejuvenation, thirty one patients with chronological aging including wrinkles, dull and dry skin with loss of elasticity and firmness. The patients received three PRP-AH injection sessions 4 weeks apart into the cheeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Regen Lab SA

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the changes of facial apparent overall assessed by FACE-Q scale. Evaluate changes in facial apparent assessed by FACE-Q scale after 6 month of Autologous Platelet Rich Plasma combined to hyaluronic acid compared to baseline (before treatment) 6 months No
Secondary Evaluate the changes of skin elasticity assessed by the Cutometer® Evaluate changes in skin elasticity assessed by the Cutometer® after 6 months of Autologous Platelet Rich Plasma combined to hyaluronic acid compared to baseline (before treatment). 6 months No
See also
  Status Clinical Trial Phase
Completed NCT04606368 - Bausch Health Thermage FXL for Use on Lower Face and Submentum Area N/A
Completed NCT01205061 - Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds N/A
Completed NCT01205048 - Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds N/A
Completed NCT02391935 - Study of Intradermal Injections of RCS-01 in Male and Female Subjects Phase 1
Completed NCT01029301 - Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System for Skin Wrinkle Treatment on Body Areas N/A
Completed NCT04861766 - Safety and Effectiveness of STYLAGE® L for Correction of Moderate and Severe Nasolabial Folds in Chinese Adults N/A
Completed NCT00114673 - A Study to Validate Cosmetic Outcome Scales Used to Rate Uneven Skin Color and Wrinkling N/A
Completed NCT00111254 - The Effects of Microdermabrasion on Skin Remodeling N/A
Completed NCT00945685 - Evaluation of Safety and Efficacy of Using Imagine™ Computerized Radiofrequency System for Skin Tightening N/A
Completed NCT05720000 - Use of Red Light Emitting Diode (LED) and Polydioxanone Thread in Glabellar Wrinkles N/A
Completed NCT01732809 - Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses Phase 4
Completed NCT06451822 - Efficacy and Performance Evaluation of mIntense L+AS 25 mg/ml Hyaluronic Acid for the Correction of Moderate to Deep Wrinkles and Folds N/A
Completed NCT00250952 - Study to Determine If the Volume Used to Dilute BOTOX Cosmetic™ for Injection Affects Its Overall Effect and Duration. N/A
Completed NCT03505684 - Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women N/A
Completed NCT00113100 - Mechanisms of Skin Repair by Topical Estrogen N/A