Reviewed:
8 August 2026
Evidence current to:
8 August 2026
The register: fifteen treatments against the record
This publication takes one non-surgical aesthetic treatment at a time and holds it against two records: the regulatory one, meaning what the US Food and Drug Administration has approved or cleared and on what terms, and the published one, meaning what has actually been measured in people and how well.
The register below is the whole argument in one table. Each row states the regulatory status, the strongest evidence available, and the point where that evidence stops. The last column is the one a page selling the treatment has no reason to print, and it is the reason this site exists.
“The safe use of these products in combination with neuromodulators ("Botox") or other treatments has not been evaluated in a controlled, clinical study.”
US Food and Drug Administration, Dermal Fillers (Soft Tissue Fillers), content current as of 6 July 2023. Toxin and filler in one appointment is among the most routinely sold combinations in American aesthetic medicine.| Treatment | US regulatory status | Best available evidence | Where it runs out |
|---|---|---|---|
| Botulinum toxin injection | Prescription drugs, FDA-approved for named facial lines in adults. Every approved product carries a boxed warning for distant spread of toxin effect. | Randomised, double-blind, placebo-controlled trials for each approved indication, reported in the prescribing information itself. | Units of one product cannot be compared with or converted into units of another. Use in combination with a filler has not been evaluated in a controlled clinical study. |
| Hyaluronic acid dermal filler | Approved devices, for adults 22 and older, each for named uses on named parts of the face or hands. | Randomised device trials scoring wrinkle or fold severity against a control, usually over months rather than years. | FDA states that repeated use over a long period has not been evaluated in a controlled study. Imaging studies keep finding gel long after the duration commonly quoted. |
| Calcium hydroxylapatite filler | Approved device for named facial uses. | Randomised trials against a comparator filler, with follow-up measured in months. | No enzyme removes it. Reversibility is a property of hyaluronic acid chemistry, not of “filler” as a category. |
| Poly-L-lactic acid injectable | Approved device. Sold as a collagen stimulator rather than a volume filler. | Device trials measuring change across several sessions, because the effect depends on a tissue response rather than on the volume placed. | The result arrives late and cannot be dialled back; nodule formation is a recognised complication and there is no reversal agent. |
| Polymethylmethacrylate–collagen filler | Approved device. Non-absorbable, so it is not designed to leave. | A randomised trial against a control filler with multi-year follow-up — a longer horizon than most filler evidence. | Non-absorbable also means an unwanted result cannot be waited out, and no enzyme dissolves it. |
| Hyaluronidase used to dissolve filler | Hyaluronidase products are FDA-approved, but not for dissolving dermal filler. That use is off-label. | Case reports and case series, not controlled trials. | The rescue a reversible treatment depends on has never been compared protocol against protocol in a controlled study. |
| Deoxycholic acid injection, under the chin | Approved drug, since 2015, for fat under the chin in adults. | Randomised, placebo-controlled trials in the approval programme. | Only the area under the chin was studied for the approval. Use elsewhere on the body is off-label and rests on smaller, uncontrolled reports. |
| Cryolipolysis (“fat freezing”) | FDA-cleared device. Clearance is not approval; it establishes substantial equivalence to a device already on the market. | Controlled studies and case series measuring fat-layer thickness by callipers or ultrasound. | Published rates for paradoxical adipose hyperplasia, the complication where the treated pad enlarges, differ between the manufacturer’s figure and independent series. |
| Ablative and non-ablative fractional laser resurfacing | Cleared devices, in numbers; the clearance route asks for equivalence, not for demonstrated benefit. | Small randomised and split-face trials, mostly single-centre. | The trial base in Fitzpatrick skin types V and VI is thinner than in I to III, and head-to-head comparisons at matched settings are scarce. |
| Intense pulsed light | Cleared devices. | Trials on pigmented and vascular lesions, generally small and short. | It is broadband light shaped by a filter rather than a laser, which makes it the least selective light source in ordinary aesthetic use. |
| Microfocused ultrasound for skin tightening | Cleared for named lift indications. | A small number of randomised studies inside a much larger uncontrolled literature. | “Lift” is in the cleared indication, so it is not a marketing invention — but the objective measurement offered for it is 1.7 mm of mean brow elevation at 90 days in 35 people, and follow-up rarely runs past a year. |
| Radiofrequency skin tightening | Cleared devices. | Small trials with short follow-up; heating does not depend on a pigment target, which is a genuine advantage in darker skin. | Durability beyond the study window, and whether device-maker settings match the settings used in the trials. |
| Radiofrequency microneedling | Cleared devices. FDA issued a safety communication on 15 October 2025 about certain aesthetic uses. | Small trials, strongest for acne scarring. | FDA names burns, scarring, fat loss, disfigurement and nerve damage among reported complications, some needing surgical repair. |
| Microneedling without energy | Some devices cleared; others sold without a device clearance at all. | Systematic reviews of acne scarring, which is where the evidence is least thin. | Needle depth, device and protocol vary so widely that “microneedling” names a range of procedures rather than one. |
| Mesotherapy, PRP, exosomes and polynucleotide injectables | No product in these categories is FDA-approved for aesthetic injection in the United States. FDA has an enforcement record on exosome products marketed for it. | Mixed and mostly small: some randomised split-face work, and for parts of this group, essentially nothing controlled. | The preparations are not standardised, so studies of “the same” treatment are frequently not comparing the same material. |
Six findings from the record
- Units of one botulinum toxin product cannot be compared with, or converted into, units of any other. A unit is defined by each manufacturer’s own potency assay, which is why a per-unit price from two clinics is not a like-for-like number. BOTOX Cosmetic prescribing information, section 5.1, revised October 2024.
- Every approved botulinum toxin product carries a boxed warning: postmarketing reports indicate the effect may spread from the area of injection. BOTOX Cosmetic prescribing information, boxed warning, revised October 2024.
- FDA has approved dermal fillers for adults 22 and older, and states that the safety of these products used repeatedly over a long period has not been evaluated in a controlled, clinical study. FDA, Dermal Fillers (Soft Tissue Fillers), content current as of 6 July 2023.
- Hyaluronidase, the enzyme a clinician reaches for when hyaluronic acid filler has to be removed, has no FDA-approved indication for dissolving filler. Reversibility rests on an off-label use, and FDA states that no product has been approved for treating filler-related symptoms. FDA-approved hyaluronidase product labelling; FDA Executive Summary, dermal filler advisory panel, 13 August 2025.
- On 15 October 2025 FDA issued a safety communication on radiofrequency microneedling, citing reported burns, scarring, fat loss, disfigurement and nerve damage from certain aesthetic uses. FDA, Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling, 15 October 2025.
- Most light-, heat- and cold-based aesthetic devices reach the US market through 510(k) clearance, which establishes that a device is substantially equivalent to one already legally marketed. It is not a finding that the device works. FDA device classification and premarket notification requirements.
What this publication counts as a source
Four kinds of document, in this order. Where a claim can only be supported further down the list, the sentence says so.
- Regulatory labelling, approvals, clearances and safety communications — the document that says what a product may be sold to do.
- Systematic reviews and meta-analyses, read for how many studies they found and how many they could use.
- Primary trials, with the sample size travelling in the sentence.
- Professional-body guidance, named as guidance rather than as evidence.
Manufacturer marketing, single case reports presented as typical, and clinic-published photography are not sources here. The full method, including the six-rung scale used to mark how strong a claim’s support is, is set out at how we read the evidence.
Reading the register
Whether any of these treatments suits you depends on your medical history, the medicines you take and what the skin or tissue in that area is actually doing. Establishing that is what a consultation with a licensed clinician is for. What this table can do is tell you what the record already settles before that appointment, and what it leaves open.
If something has already gone wrong, or an advertisement or a bill looks improper, the official channels and what each one can actually act on are listed at where to report.
Reviewed: 8 August 2026 · Evidence current to: 8 August 2026