Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster

Phase 4

Completed

Conditions: Facial Aesthetic Treatment

Interventions: Drug: Azzalure
Device: Restylane/Emervel filler
Device: Restylane Skinbooster

Registration Number: NCT02297503

Lead Sponsor: Galderma R&D

Brief Summary: The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects requiring treatment of forehead lines or crow´s feet.
Obvious facial sagging (major loss of facial fat/volume).
Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity.
Heavily scarred or sun-damaged facial skin.
Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster/herpes simplex near or on the areas to be treated.
Cancerous or pre-cancerous lesions in the areas to be treated.
Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA) or collagen, or botulinum toxin treatment during the last 12 months.
Procedures or treatments inducing an active dermal response such as laser, Intense Pulsed Light, chemical peeling, microdermabrasion, retinoids within the last 6 months.
Any aesthetic surgery of the face.
Permanent implant or aesthetic treatment with non-HA or non-collagen products in the face.
History of severe keloids and/or hypertrophic scars.
Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis) or history of dysphagia and aspiration.
Known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or other amide-type anesthetics.
History of autoimmune diseases.
Any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment).
Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs [NSAIDs]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.
Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months prior to baseline visit.
Female subjects who are pregnant or plan to become pregnant within the study timeframe, or who are nursing.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azzalure alone as single treatment	Azzalure	Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
Azzalure alone as single treatment	Restylane/Emervel filler	Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
Azzalure alone as single treatment	Restylane Skinbooster	Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
Filler alone as single treatment	Azzalure	HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
Filler alone as single treatment	Restylane/Emervel filler	HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
Filler alone as single treatment	Restylane Skinbooster	HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)	7 months	To evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)	1, 7 and 13 months	To evaluate "Global facial aesthetic appearance" at 1, 7 and 13 months, blinded evaluator review of photographs from the respective visits.
Injected Filler Volume	Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12)	To evaluate the filler volume injected at initial single treatment and at following repeated combined treatment
Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)	Month 7 and Month 13	Subjects answered the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Number of subjects satisfied are those that answered "Very/somewhat satisfied".
Adverse Event Reporting	0-18 months	To evaluate safety throughout the study period
Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)	Month 7 and Month 13	The wrinkle severity of the glabellar lines at maximum frown was evaluated by the investigator at baseline before first treatment and at follow-up visits. Validated photonumeric grading scales were used where each severity grade is illustrated by a set of photographs. The investigator performed the assessment live or by using 2D photographs from the present visit, together with the respective photo guide: 0 No glabella lines, 1 Mild glabella lines, 2 Moderate glabella lines, 3 Severe glabella lines, 4 Very severe glabella lines. Improved criteria is thus fulfilled for subjects receiving a lower score compared to baseline.
Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator	Month 1, Month 7, and Month 13	The 5-graded GAIS is used to assess the facial aesthetic improvement from baseline by responding to the question: "How would you describe the subject's global facial aesthetic appearance, compared to the photographs taken before treatment at baseline?" The scale grades are Very much improved, Much improved, Somewhat improved, No change, Worse. Improved subjects are those graded as Very much improved, Much improved, and Somewhat improved.
Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome	Month 7 and Month 13	The Investigator answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is met for those subjects that the Investigator answered "Very/somewhat satisfied".
Change in Perceived Age of Subjects	1 and 7 months, and 1 and 13 months	To evaluate First impression and perceived age of subjects by evaluation of photos. Change between timepoints are reported. A negative value indicates that the participant is assessed to be younger at the specified visit compared to the assessment made at 1 month after single treatment.

Trial Locations

Locations (3): Mediti Center
🇫🇷
Paris, Antibes, France
Centre Medical Saint-Jean
🇫🇷
Arras, France
Akademikliniken
🇸🇪
Stockholm, Sweden
Mediti Center
🇫🇷Paris, Antibes, France