Article by Dr. Patricia Gutiérrez Ontalvilla, MD, PhD, plastic surgeon specialized in regenerative medicine and vulvar lichen sclerosus.
“Can this be regenerated?” is the question you ask me most often, both in consultation and on social media. To answer it properly requires a preliminary step that is almost never explained: understanding what it means for a study to have “level 1 evidence.” Without that context, any headline about tissue regeneration sounds equally reliable, whether it has a rigorous trial behind it or a loose opinion.
This article does not compare treatments with each other. It explains how to read the scientific evidence behind them, using as a real example the trial that gave rise to the Liquenia protocol and the studies that have followed it.
What is a level of scientific evidence?
Medical research classifies studies according to their ability to demonstrate that a treatment actually works, and not that the result is due to chance or other factors. This classification is represented as a pyramid: at the base are expert opinion and case series; at an intermediate level, observational studies; and near the top, randomized clinical trials.
A randomized clinical trial randomly assigns participants between groups, in order to compare one treatment against another (or against placebo) with the least possible bias. When well designed, it is considered level 1 evidence: the type of individual study with the greatest strength to establish a cause-and-effect relationship.
Level of evidence is not the same as absolute truth. It is a way of saying how much we can trust, today, a specific conclusion, with the available data.
The 2022 trial: why it is considered level 1
The starting point of the Liquenia protocol is a randomized clinical trial published in Aesthetic Plastic Surgery (2022). By randomly assigning participants between comparable groups, this design made it possible to observe improvement in symptoms, signs and tissue quality with a higher level of confidence than that of an isolated case series. [VERIFY SOURCE: exact DOI and sample size of the APS 2022 trial before publishing].
Understanding this matters especially if you have been searching for answers for a long time. European studies place the average diagnostic delay for vulvar lichen sclerosus between 5 and 7 years (Pérez-López et al., Climacteric, 2017), a period during which many women consult forums, social media and artificial intelligence before reaching a specialized consultation. The more years of waiting, the more important it is to know how to distinguish a level 1 trial from a well-told anecdote.
What about the 2025 studies? Case series with biopsy
The results published in Aesthetic Surgery Journal (2025) and Aesthetic Plastic Surgery (2025) are not randomized trials: they are case series with histological confirmation by biopsy. This design occupies a lower rung on the evidence pyramid than the 2022 trial, because it does not compare groups at random, but it provides something different and valuable: detailed documentation, with tissue analyzed under a microscope, of what happens in real clinical practice after applying the stromal vascular fraction (SVF).
Average diagnostic delay in vulvar lichen sclerosus (Pérez-López et al., Climacteric, 2017)
Patients included in the case series with biopsy (Gutiérrez-Ontalvilla et al., Aesthetic Surgery Journal, 2025, trial NCT03961126)
No isolated study, however solid its design, replaces individual medical assessment. Level 1 evidence confirms that something works on average, in a comparable group of patients; it does not guarantee a specific result for each woman.
What this means for you as a patient
When you read about a treatment for lichen sclerosus, on social media or on any website, it may help to ask: what type of study is behind it? Did it compare groups at random or does it describe cases already treated? Is it published in a peer-reviewed journal? That information usually indicates, in a few lines, how much real weight the claim has.
Therefore, when I say that lichen sclerosus “cannot be cured, but its course can be modified,” it is not a prudent way of speaking: it is what the available evidence allows us to state, no more, no less. The ISSVD (2022) defines lichen sclerosus as a chronic condition that can be controlled; no current level of evidence supports speaking of cure.
I do not promise cure. I show what has been published.
Dr. Patricia Gutiérrez Ontalvilla
References
- Randomized clinical trial, Aesthetic Plastic Surgery (2022), level 1 evidence. [VERIFY SOURCE: complete reference and DOI]
- Gutiérrez-Ontalvilla et al. Case series with histological biopsy. Aesthetic Surgery Journal (2025). DOI: 10.1093/asj/sjaf148. Registered trial: NCT03961126.
- Case series, Aesthetic Plastic Surgery (2025). [VERIFY SOURCE: complete reference and DOI]
- Pérez-López FR, et al. Diagnostic delay in vulvar lichen sclerosus. Climacteric (2017).
- ISSVD. Consensus document on vulvar lichen sclerosus (2022).
Frequently asked questions
What is “level 1 evidence” in medicine?
It is the classification given to well-designed randomized clinical trials, in which participants are randomly assigned between comparable groups. It is the highest level among individual studies to demonstrate that a treatment produces a real effect, above case series or expert opinions.
Does the 2022 study prove that lichen sclerosus is cured?
No. It demonstrates improvement in symptoms, signs and tissue quality within the studied design. No current level of evidence supports speaking of cure: lichen sclerosus is described as a chronic condition whose course can be modified with appropriate treatment.
Why do the 2025 studies have a lower level of evidence than the 2022 one?
Because they are case series with biopsy confirmation, not randomized trials with a comparator group. They provide valuable information about what happens in real clinical practice, but individually they weigh less, in the evidence hierarchy, than a well-designed trial.
Should I distrust a treatment if it does not have level 1 evidence?
Not necessarily. It is advisable to understand what type of study supports it and what that design can or cannot claim. When in doubt, the best source remains an individualized medical assessment with a specialist in vulvar lichen sclerosus.
Would you like us to assess your case with this evidence on the table?
In a medical assessment we can explain to you, with your medical history in front of us, which options fit your situation and what the available evidence actually says about them.
If you want to delve deeper into how this evidence applies to vulvar tissue, you can also read what science says about regenerating tissue in lichen sclerosus and why the Liquenia-SVF protocol reaches where corticosteroids cannot. You can consult my complete scientific publications at dragutierrez.com and the research work of the Nixarian Foundation. Excellent Cum Laude Doctoral Thesis by Dr. Patricia Gutiérrez Ontalvilla (MD, PhD) with the title: Pilot study of the treatment of vulvar lichen sclerosus using adipose tissue associated with autologous platelet-rich plasma.
This article is for informational purposes and does not replace diagnosis or individualized medical advice. In the presence of persistent symptoms, pain, fissures or visible changes, consult with gynecology, dermatology or a specialist in vulvar pathology.
