Open-label, multicenter, uncontrolled, randomized, post market clinical follow-up (PMCF) study to confirm effectiveness and safety of Belotero® Revive in facial skin revitalization and photo-damaged skin treatment
- Conditions
- EARLY-ONSET PHOTO-DAMAGED FACIAL SKI
- Registration Number
- DRKS00025699
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 159
1. Written informed consent obtained from the subject;
2. Female or male = 25 to 45 years old;
3. Subjects with early signs of facial photo-damaged skin (as assessed on investigators judgement based on i.e., uneven skin tone, fine lines, dehydrated skin) who is looking for an improvement of their skin quality/skin revitalization and aesthetic appearance;
4. Subject is willing to abide from all (aesthetic) facial procedures (e.g., other dermal fillers outside of this study, toxin treatments, any resurfacing procedures e.g., facial ablative or fractional laser, microdermabrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy®], and surgical procedures) in the area to be treated during participation in the study;
5. Woman of childbearing potential must be using a highly effective method of birth control.
Subjects who had:
1. A recent or current history of inflammatory skin disease (e.g., acne), infection, cancerous/pre-cancerous lesion, unhealed wound in the proposed treatment areas. Have a history of systemic granulomatous diseases active or inactive (e.g., sarcoid, Wegeners, tuberculosis, etc.) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.) with the potential to interfere with the study results or increase the risk of adverse events (AEs);
2. Actinic damaged skin, severe solar elastosis and/or premature aging skin in the area to be treated;
3. Begun use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the target areas within 90 days prior to enrollment or is planning to begin use of such products during participation in the study.
4. A history of the following cosmetic treatments in the area(s) to be treated:
4.1 Skin tightening procedure within the past 12 months (e.g., Ultherapy);
4.2 Injectable filler of any type within the past:
-12 months for hyaluronic acid fillers (e.g., Belotero® Balance);
-12 months for calcium hydroxyapatite
fillers (e.g., Radiesse®);
-24 months for poly-L-lactic acid fillers (e.g., Sculptra®);
-Ever been treated with silicone, polymethyl methacrylate (PMMA), fat injections, or permanent dermal fillers (e.g., Silicone).
4.3 Botulinumtoxins within the past 3 months;
4.4 Ablative resurfacing laser treatment within the past 24 months;
4.5 Nonablative, rejuvenative laser or light treatment within the past 6 months;
4. 6 Surgical dermabrasion or deep facial peels within the past two years.
5. A propensity towards pigmentary skin changes, such as hyper- or hypopigmentation in the face, keloid formation, or hypertrophic scarring.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of skin hydration value (Corneometry) 8 weeks after the last repeated injection (Week 16, treatment arm 1).
- Secondary Outcome Measures
Name Time Method 1) Change of skin hydration value (Corneometry) 8 weeks after the single injection (Week 8, treatment arm 2)<br>2) Value of skin hydration (Corneometry) at all visits;<br>3) Changes of skin hydration (Corneometry) from baseline to all further visits after the first injection;<br>4)Treating investigator’s evaluation of the global aesthetic improvement on the Investigator’s Global Aesthetic Improvement Scale (iGAIS) from Day 1 pre injection photographs to all further visits;<br>5) Subject’s evaluation of the global aesthetic improvement on the Subject’s Global Aesthetic Improvement Scale (sGAIS) from Day 1 pre-injection photographs to all further visits;<br>6) FACE-Q – Satisfaction with Facial Appearance, change from baseline to all visits of the total score;<br><br><br><br>