Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the improvement in signs of photoaging and subject satisfaction after combination, global facial and/or neck treatment with IncobotulinumA (Xeomin), HA (Belotero) and/or calcium hydroxyapatite (Radiesse+, Radiesse Classic). All products will be used on-label FDA-cleared indications.


Clinical Trial Description

Facial and neck aging is multifactorial, resulting from changes in anatomical aspects combined with changes in the skin integrity. The 5 key signs of photoaging will be evaluated both objectively and subjectively including: fine lines and wrinkles, enlarged pores, sagging skin, pigmentation and redness/flushing. These aspects of the aging face are often bothersome to patients who seek aesthetic treatments for correction. Injectables, including IncobutolinumtoxinA, hyaluronic acid (HA), and calcium hydroxyapatite, have grown in popularity over the past decade due to their safety profiles, favorable results, and longevity. IncobutolinumtoxinA allows for correction of rhytides, while HA and calcium hydroxyapatite allow for lifting, contouring, and overall re-volumization. Further, calcium hydroxyapatite effectively restores volume and can improve skin texture through its biostimulatory effects, which have been well studied in the literature. Through inducing collagen formation in the skin, calcium hydroxyapatite can also improve skin quality and thickness. In contrast to volumization effects, the overall improvement in skin quality has not been as well studied. Further, it has been observed by patients and physicians that global treatment with toxins and fillers can produce a better result in skin texture than each agent on its own. This study will consist of one treatment visit for global facial treatment using toxin and fillers (Xeomin, Radiesse+, Radiesse Classic, Belotero Balance) to enhance signs of facial photoaging and appearance. This clinical investigation is a prospective study consisting of a screening/treatment visit and 3 follow-up visits. A total of 20 patients will be recruited. Following informed consent and screening, each eligible subject will be photographed with the Canfield Visia system. They will be treated at Baseline Visit (Day 0) with Xeomin, Belotero Balance, Radiesse+, and/or Radiesse Classic. Determination of which facial and/or neck areas to be treated will be made after assessment by the investigator and discussion with the patient. All products will be used on-label in their FDA-cleared manner. Post-treatment, patients will be instructed to apply ice to all areas for 3-5 minutes immediately afterwards. The patient will return at post-treatment months 1 and 3 for GAIS and FACE-Q Subject Satisfaction and photography with the Canfield Visia system. A blinded independent evaluator will evaluate the baseline and post-treatment photographs on a 5-point scale for fine lines and wrinkles, enlarged pores, redness, flushing, pigmentation, and sagging skin. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05039723
Study type Interventional
Source Main Line Center for Laser Surgery
Contact
Status Active, not recruiting
Phase Phase 4
Start date September 1, 2021
Completion date September 1, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05027282 - Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment N/A
Completed NCT04911374 - An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream N/A
Completed NCT04586816 - Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging N/A
Not yet recruiting NCT05004909 - Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream N/A
Completed NCT03661697 - Combination Versus Laser Treatment Only N/A
Completed NCT03948945 - Efficacy and Safety of Profile HaloTM Mixed Fractional Laser on Treating of Facial and Neck Photoaging. N/A
Not yet recruiting NCT04869852 - Effects of Mango Intake on Skin Health and Gut Microbiome Changes in Postmenopausal Women N/A
Not yet recruiting NCT02126644 - The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Photoaging Phase 2
Active, not recruiting NCT01372566 - Effect of Platelet Rich Plasma on Photoaged Skin Phase 1/Phase 2
Unknown status NCT00842907 - Efficacy and Safety of Oral Isotretinoin for Cutaneous Photodamage Phase 2
Active, not recruiting NCT03112863 - Comparison of the Cosmetic Effects of Bakuchiol and Retinol Phase 1/Phase 2
Recruiting NCT03421691 - A Single-Center Open-Label Study of 1064 nm Nd:YAG for Nonablative Skin Rejuvenation N/A
Not yet recruiting NCT04871750 - Effects of Dietary Soy Protein on Facial Wrinkles in Postmenopausal Women N/A
Not yet recruiting NCT03144193 - Efficacy in Daily Use of a Novel Skin Care Product for the Treatment of Photoaged Skin N/A
Completed NCT01935310 - Photoaging Treatment With Imiquimod N/A
Completed NCT00701740 - Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial Phase 2
Completed NCT04345094 - Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging N/A
Recruiting NCT02468453 - VELOS for the Treatment of Vascular Lesions and Skin Rejuvenation N/A
Recruiting NCT04769193 - A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity N/A
Completed NCT01406080 - A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging Phase 3