A Prospective, Multicenter, Evaluator-Blinded, Randomized Study of Diluted Calcium Hydroxylapatite to Treat Decollete Wrinkles

July 2024 | Volume 23 | Issue 7 | 551 | Copyright © July 2024


Published online June 24, 2024

doi:10.36849/JDD.8261

Tatjana Pavicic MDa, Martina Kerscher MDb, Ulrich Kuhne MDc, Iryna Heide MDd, Hanna Dersch e, Gemma Odena PhDf, Virginia Graul PhDf

aPrivate Practice for Dermatology and Aesthetics, Munich, Germany
bUniversity of Hamburg, Hamburg, Germany
cHautmedizin Bad Soden, Bad Soden, Germany
dFormerly Merz Aesthetics GmbH, Frankfurt am Main, Germany (currently Boehringer Ingelheim, Ingelheim, Germany)
eMerz Aesthetics GmbH, Frankfurt am Main, Germany
fGlobal Clinical Development, Merz North America, Raleigh, NC

Abstract
Background: Calcium hydroxylapatite (CaHA) dermal filler is used for a variety of aesthetic treatments; however, the safety and effectiveness of diluted CaHA for the treatment of décolleté wrinkles have not been established.
Objective: To demonstrate the effectiveness and safety of diluted CaHA (Radiesse; 1:2 CaHA:saline) injection for the improvement of décolleté wrinkles in females.
Methods: Eligible females with moderate or severe ratings on the Merz Aesthetic Scale (MAS) Decollete Wrinkles - At Rest received up to 3 injection cycles of diluted CaHA either 8 weeks apart (3 injection cycles) or 16 weeks apart (2 injection cycles). Effectiveness was evaluated by improvement on the MAS. Adverse events were recorded over a 52 week period.
Results: Sixteen weeks after the last treatment, the response rate (1-point improvement or greater) on the MAS Decollete Wrinkles - At Rest was 73.5% (P<0.0001; pooled sample) for all patients. The use of diluted CaHA in the decollete also demonstrated a favorable safety profile.
Conclusions: Diluted CaHA is a safe and effective treatment for the improvement of decollete wrinkles in females.

J Drugs Dermatol. 2024;23(7):551-556.  doi:10.36849/JDD.8261

INTRODUCTION

Skin, like most organs, undergoes deleterious changes with the passage of time. A primary component of skin aging is the degradation of the extracellular matrix, which is marked by a decrease in fibroblast quantity and activity; this degradation clinically manifests as wrinkling, fat loss, and worsening skin quality.1 Maintaining good skin quality requires sufficient skin firmness, surface evenness, tone evenness, and glow. All of these characteristics are affected by multiple tissue layers, which are influenced by aging.2 

Additionally, in contrast to other organs, skin is also directly affected by exposure to the environment, especially chronic ultraviolet radiation from the sun, which results in photoaging. As a result, areas of the body frequently exposed to the sun, such as the face, neck, decollete, forearms, and dorsal hands, show visible signs of aging more rapidly than other areas of the body.3-5

Furthermore, in females, the decollete is vulnerable to the mechanical stresses associated with the weight and movement of the breasts. Females are also more prone to decollete aging due to hormonal changes from menopause and estrogen deficiency. These changes result in an accelerated breakdown of collagen and elastin, leading to skin thinning and laxity, and worsening of lines and wrinkles.6 

Addressing these variable conditions can be challenging for the aesthetic physician. While facial rejuvenation is well-established, interest in rejuvenation procedures for more intricate areas, such as the decollete, has recently increased. Current modalities used to treat signs of aging in the décolleté region include neurotoxins, fillers, chemical peels, intense pulsed light, non-ablative and ablative lasers, and microfocused ultrasound with visualization.7,8