Open, Non-Comparative Study To Evaluate The Performance Of The Medical Device JANESSE®

NCT04103125 | Completed

• 1 other identifier: OPIRA/0119/MD
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this clinical investigation is that in a population of men and women affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will cross-linked hyaluronic acid (Janesse) significantly decrease the appearance of facial wrinkles, results observed after 4, 8 and 12 weeks.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (2)

• WSRS score assessed by the Investigator

  To evaluate the overall safety of the medical device and performance of Janesse® dermal filler in terms of absolute change of WSRS score (Wrinkle Severity Rating Scale) assessed by Investigator at 4, 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).

  12 weeks

• AE, SAE, ADE, SADE incidence

  AE, SAE, ADE, SADE incidence

  12 weeks

Secondary Outcomes (6)

• WSRS score assessed by the patient

  12 weeks

• Global Aesthetic Improvement Scale evaluated by the subject

  12 weeks

• Treatment satisfaction questionnaire completed by the subject

  12 weeks

• Investigator Global Assessment of Performance (IGAP)

  12 weeks

• Investigator Global Assessment of Safety (IGAS)

  12 weeks

Study Arms (1)

Janesse

OTHER

Janesse® 20 (Cross-linked Hyaluronic Acid) Injection: follow the instruction for use

Device: Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.

Interventions

Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. DEVICE

The subjects will receive at baseline the first IMD by the Investigator in accordance with the CIP

Janesse

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women with age \> 35 and ≤ 65 years.
• Subjects with nasolabial wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler;
• Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS);
• Subjects who agree to discontinue all dermatological treatment and procedures during the study;
• Subjects willing to provide signed informed consent to clinical investigation participation.
• Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

You may not qualify if:

• Subjects who have bleeding disorder in the past or present.
• Use of aspirin and antiplatelet agents a week prior to treatment
• Prior or planned use of topical injection to the face (steroid, retinoid: applicable only to drugs, not applicable to cosmetics), within 4 weeks prior to screening or during this study (steroid ointment for therapeutic objectives is allowed for short -term use of ≤14 consecutive days.).
• Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening.
• History of anaphylaxis or severe complicated allergy symptoms.
• Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study.
• Hypersensitivity skin reaction to the investigational device based on intradermal test results at screening.
• Evidence or history of autoimmune disease or compromised immune system.
• Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation;
• Prior permanent fillers or fat graft procedures around nasolabial folds.
• Wrinkle correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photorejuvenation, etc.) within 6 months prior to study participation.
• History of hypersensitivity to local anesthetic of amide type or HA.
• History of keloid formation or hypertrophic scar on the face.
• Evidence of active infection on the face.
• Wound, scar, or skin disorder or infection around nasolabial folds that may affect the efficacy assessment.

Sponsors & Collaborators

• I.R.A. Istituto Ricerche Applicate S.p.A.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

SCM Dr. Rosu

Timișoara, Timiș County, 300425, Romania

Location

Related Publications (16)

• Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM. Update on facial aging. Aesthet Surg J. 2010 Jul-Aug;30 Suppl:11S-24S. doi: 10.1177/1090820X10378696.

  PMID: 20844296 BACKGROUND

• Kim BW, Moon IJ, Yun WJ, Chung BY, Kim SD, Lee GY, Chang SE. A Randomized, Evaluator-Blinded, Split-Face Comparison Study of the Efficacy and Safety of a Novel Mannitol Containing Monophasic Hyaluronic Acid Dermal Filler for the Treatment of Moderate to Severe Nasolabial Folds. Ann Dermatol. 2016 Jun;28(3):297-303. doi: 10.5021/ad.2016.28.3.297. Epub 2016 May 25.

  PMID: 27274627 BACKGROUND

• Few J, Cox SE, Paradkar-Mitragotri D, Murphy DK. A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. Aesthet Surg J. 2015 Jul;35(5):589-99. doi: 10.1093/asj/sjv050. Epub 2015 May 11.

  PMID: 25964628 BACKGROUND

• Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013.

  PMID: 23687448 BACKGROUND

• Dong J, Gantz M, Goldenberg G. Efficacy and safety of new dermal fillers. Cutis. 2016 Nov;98(5):309-313.

  PMID: 28040813 BACKGROUND

• De Boulle K, Heydenrych I. Patient factors influencing dermal filler complications: prevention, assessment, and treatment. Clin Cosmet Investig Dermatol. 2015 Apr 15;8:205-14. doi: 10.2147/CCID.S80446. eCollection 2015.

  PMID: 25926750 BACKGROUND

• Rivkin AZ. Volume correction in the aging hand: role of dermal fillers. Clin Cosmet Investig Dermatol. 2016 Aug 30;9:225-32. doi: 10.2147/CCID.S92853. eCollection 2016.

  PMID: 27621659 BACKGROUND

• Kuhne U, Esmann J, von Heimburg D, Imhof M, Weissenberger P, Sattler G. Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting - an open-label, multicenter study. Clin Cosmet Investig Dermatol. 2016 Oct 20;9:373-381. doi: 10.2147/CCID.S115256. eCollection 2016.

  PMID: 27799807 BACKGROUND

• Lorenc ZP, Bank D, Kane M, Lin X, Smith S. Validation of a four-point photographic scale for the assessment of midface volume loss and/or contour deficiency. Plast Reconstr Surg. 2012 Dec;130(6):1330-1336. doi: 10.1097/PRS.0b013e31826d9fa6.

  PMID: 23190816 BACKGROUND

• McCall-Perez F, Stephens TJ, Herndon JH Jr. Efficacy and tolerability of a facial serum for fine lines, wrinkles, and photodamaged skin. J Clin Aesthet Dermatol. 2011 Jul;4(7):51-4.

  PMID: 21779421 BACKGROUND

• Rzany B, Cartier H, Kestemont P, Trevidic P, Sattler G, Kerrouche N, Dhuin JC, Ma YM. Full-face rejuvenation using a range of hyaluronic acid fillers: efficacy, safety, and patient satisfaction over 6 months. Dermatol Surg. 2012 Jul;38(7 Pt 2):1153-61. doi: 10.1111/j.1524-4725.2012.02470.x.

  PMID: 22759252 BACKGROUND

• Van Dyke S, Hays GP, Caglia AE, Caglia M. Severe Acute Local Reactions to a Hyaluronic Acid-derived Dermal Filler. J Clin Aesthet Dermatol. 2010 May;3(5):32-5.

  PMID: 20725567 BACKGROUND

• Funt D, Pavicic T. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches. Plast Surg Nurs. 2015 Jan-Mar;35(1):13-32. doi: 10.1097/PSN.0000000000000087.

  PMID: 25730536 BACKGROUND

• Ghooi RB, Bhosale N, Wadhwani R, Divate P, Divate U. Assessment and classification of protocol deviations. Perspect Clin Res. 2016 Jul-Sep;7(3):132-6. doi: 10.4103/2229-3485.184817.

  PMID: 27453830 BACKGROUND

• Jiang LI, Stephens TJ, Goodman R. SWIRL, a clinically validated, objective, and quantitative method for facial wrinkle assessment. Skin Res Technol. 2013 Nov;19(4):492-8. doi: 10.1111/srt.12073. Epub 2013 Jun 10.

  PMID: 23750828 BACKGROUND

• Stephens TJ, Sigler ML, Herndon JH Jr, Dispensa L, Le Moigne A. A placebo-controlled, double-blind clinical trial to evaluate the efficacy of Imedeen((R)) Time Perfection((R)) for improving the appearance of photodamaged skin. Clin Cosmet Investig Dermatol. 2016 Mar 15;9:63-70. doi: 10.2147/CCID.S98787. eCollection 2016.

  PMID: 27042135 BACKGROUND

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mihaela Fratila

  SCM Dr. Rosu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a multi-center, open-label, non-randomized, single group clinical investigation

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 25, 2019
• Study Start: July 14, 2020
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

RO (1)