Allergan Aesthetics Phase 4 readout offers directionally encouraging but pivotal-weight deficient evidence in GLP-1 associated facial change. [1] HARMONY IN DIVERSITY reported a statistically significant 42.4-point improvement in FACE-Q Satisfaction With Facial Appearance at 30 days in 30 participants on a triple regimen of HA injectables plus onabotulinumtoxinA plus skincare, while interim HALO reported a 39.6-point mean improvement at month 3 in 25 participants on HA injectables alone with 95.7% satisfied they still looked like themselves, presented at ASDS 2026. Contextual coherence comes from two mechanistically matched GLP-1 peers: a 2025 multicenter open-label study in 41 subjects with cheek wrinkles and midface deficiency after GLP-1 RA weight loss using PLLA-SCA plus HA-LYF or HA-CON through 9 months, and a Latin American real-world case series in 15 women with 17.9% weight reduction showing FLRS 4.5 to 2.6 and WSRS 3.1 to 1.9 at D90. [1] Market pull is visible in a 406-HCP survey reporting 137% growth in GLP-1 patient flow and HA preferred for 47% of facial concerns, supporting self-pay adoption but no HTA or ICER case. [2] No closely comparable regulatory precedent exists for GLP-1 facial change, so this package supports promotion and protocol development, not label expansion, with safety in co-medicated patients still uncharacterized given a late edema report with Ozempic co-use. [1]
42.4-point and 39.6-point FACE-Q gains rest on n=30 and n=25 interim single-arm Phase 4 data with no comparator and confounded triple therapy.
| Indication | Aesthetic improvement for facial changes due to GLP-1 medication use |
| Drug | onabotulinumtoxinA and Hyaluronic Acid injectables |
| Mechanism of Action | Neurotoxin, Dermal Filler |
| Company | Allergan Aesthetics |
| Trial Phase | Phase 4 |
| Trial Acronym | HARMONY IN DIVERSITY, HALO |
| Category | Clinical Trial Event |
| Sub Category | Topline Results Positive |
| Therapeutic Area | Others |
| Patient Population | Adults on GLP-1 medications |
| Study Design | Prospective, multicenter, open-label, single-arm |
| HARMONY IN DIVERSITY Participants | 30 |
| HALO Interim Participants | 25 |
| Primary Outcome Measure | FACE-Q Satisfaction With Facial Appearance |
| HARMONY IN DIVERSITY Mean Improvement | 42.4 points |
| HALO Mean Improvement | 39.6 points |
| Conference Name | 2026 American Society for Dermatologic Surgery (ASDS) Annual Meeting |
| Presentation Dates | Nov. 5-8, 2026 |
| Parent Company | AbbVie |
Allergan Aesthetics Reports Positive Phase 4 Results for GLP-1 Patients
Allergan Aesthetics, an AbbVie company, announced positive results from two Phase 4 studies, HARMONY IN DIVERSITY and HALO, evaluating aesthetic treatments in adults on GLP-1 medications. The HARMONY IN DIVERSITY study, combining HA injectables, onabotulinumtoxinA, and skincare, showed a statistically significant 42.4-point improvement in FACE-Q Satisfaction With Facial Appearance at 30 days in 30 participants. Interim results from the HALO study, using HA injectables in 25 participants, demonstrated a 39.6-point mean improvement in FACE-Q Satisfaction With Facial Appearance at month 3, with 95.7% satisfied they still looked like themselves. These findings, presented at ASDS 2026, address facial changes experienced by GLP-1 users.
- The HARMONY IN DIVERSITY (Cohort 2) study, involving 30 adults on GLP-1 medications, demonstrated significant aesthetic and psychosocial benefits. Participants treated with HA injectables, onabotulinumtoxinA, and a skincare regimen reported a 42.4-point mean improvement in FACE-Q Satisfaction With Facial Appearance, along with statistically significant improvements in skin quality, psychological function, and social function. Most treatment-related adverse events were mild and nonserious.
- The HALO study's interim analysis of 25 GLP-1 patients treated with HA injectables across the face showed high patient satisfaction. Participants experienced a 39.6-point mean improvement in FACE-Q Satisfaction With Facial Appearance from before treatment to month 3. Notably, 95.7% were satisfied or very satisfied that they still looked like themselves, and 82.6% were satisfied with how natural they looked.
- These studies specifically target facial changes, such as volume loss and altered skin quality, experienced by individuals using GLP-1 medications for weight loss. The data provide crucial evidence for healthcare providers to develop informed treatment plans, helping patients manage their self-image and social engagement, and highlighting the importance of tailored aesthetic approaches for this growing patient population.
Addressing Facial Changes in the GLP-1 Patient Population
GLP-1 receptor agonists such as semaglutide and tirzepatide have expanded beyond type 2 diabetes mellitus and obesity into off-label use for esthetic weight reduction, driving a growing population presenting with facial volume loss, skin laxity and prematurely aged appearance termed "Ozempic face." Quantitative and observational data from 2023 to 2026 characterize this as loss of midfacial volume, dermal thinning, loss of collagen and elastin fibers, decreased skin elasticity, redundant skin folds and pronounced wrinkles.
Affected patient population: Adults receiving glucagon-like peptide-1 receptor agonists including semaglutide, liraglutide and tirzepatide for diabetes and obesity management and for off-label esthetic weight reduction, including patients studied with median age of 54 years (interquartile range [IQR] 48-61), case series aged 27-65 years, and adults aged 30-50 with BMI >30 kg/m; risk factors for more severe dermatological outcomes included advanced age, prolonged obesity history, rapid weight loss, poor hydration, and insufficient protein intake.
Facial burden targeted for correction: Prematurely aged and fatigued facial appearance due to rapid weight loss with depletion of facial volume and fat resulting in wrinkles and sagging skin; median percent decrease in total midfacial volume was 9.0% (IQR 3%-14%), superficial volume decreased by 11.0% (IQR 5%-15%), and deep volume decreased by 7.0% (IQR -20% to 15%), with loss of 7% facial volume for every 10 kg of weight lost primarily in superficial fat pads.
Lack of standardized management pathways: Gaps in empirical data, optimal timing for interventions, and standardized guidelines for treating this unique patient population, with systematic studies on the effectiveness and safety of corrective treatment lacking and prospective clinical validation still required.
Need for defined mechanistic and personalized strategies: Further studies needed to understand molecular mechanisms of skin and fat changes including collagen degradation, fat loss, skin elasticity, dermal structure alterations, adipose compartment loss, and fat distribution over time, and to develop personalized, multimodal treatment strategies combining injectable treatments, energy-based devices, and surgical interventions with imaging tools and psychological support; findings revealed a 40% increase in filler consultations attributed to GLP-1-related aesthetic concerns.
HARMONY IN DIVERSITY and HALO: Designing for GLP-1 Aesthetic Needs
This regimen was evaluated in a multicenter, open-label study in subjects with cheek wrinkles and midface contour deficiencies following GLP-1 RA-driven weight loss. Subjects received sequential poly-L-lactic acid and hyaluronic acid midface fillers to restore facial balance, correct contour deficiencies, and improve skin quality.
| Study design | Population | Treatment regimen | Follow-up | Efficacy endpoints | Safety monitoring |
|---|---|---|---|---|---|
| Multicenter, open-label study of PLLA-SCA and 2 hyaluronic acid midface fillers (HA-LYF, HA-CON) | 41 subjects with cheek wrinkles and midface contour deficiencies following GLP-1 RA-driven weight loss | 2 to 3 treatment sessions of PLLA-SCA and 1 to 2 treatment sessions of HA-LYF or HA-CON | Through 9 months since the last PLLA-SCA treatment | Objective skin quality assessments using bioinstrumentation; improvements in facial contour deficiencies using standardized photography; subject self-assessment questionnaires; significant improvement in facial skin quality and enhanced contour in the cheek, jawline, and perioral areas with objective improvement in hydration and skin radiance and subject satisfaction with treatment results | Safety monitored throughout the study with no treatment-related adverse events reported |
Frequently Asked Questions
References
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