Evaluation of Effectiveness, Duration and Anti-Aging Properties of Sofiderm^® Hyaluronic Acid Filler: An Analysis Based on VisiaCR5 Data

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

This article has not a sound scientific design. It compares different cases. 

This is an enormous bias. 

The number of cases is too low to be able to draw conclusions. 

The style renders the article unclear. An example is the following sentence:

"Our prospective, single-arm non-randomized study intends to evaluate 102
the corrective capacity and duration of 3 HA filler products from the Sofiderm® , and to 103
understand whether there is a direct correlation between the Griffiths photoaging evalu- 104
ation scale, widely used in the literature in order to standardize the results obtained in 105
facial rejuvenation procedures, and the data reported by the PRIMOS software, an emerg- 106
ing tool, also aimed at objectifying the results obtainable through aesthetic medicine pro- 107
cedures."

What is actually the aim of this study? How can one evaluate the corrective capacity and duration of a filler on 4 patients? 

The design of this study is not scientifically sound> I do not think that it can be accepted for publication in this form. 

 

 

 

 

Author Response

Response to Reviewers

We sincerely thank the reviewers for their insightful and constructive comments, which have significantly contributed to improving the quality and clarity of our manuscript. Below we provide a detailed point-by-point response.

 

Reviewer 1

1. "The article lacks sound scientific design and compares different cases."
   Response:We acknowledge this limitation. The study is presented as an exploratory pilot study without a control group. We have clarified this in the abstract, methods, discussion, and conclusions. The personalized treatment approach mirrors real-world practice but is now explicitly framed as a potential bias in our analysis.
2. "The number of cases is too low to draw conclusions."
   Response:Agreed. We have adjusted the tone of the manuscript to reflect the exploratory and preliminary nature of the findings. No definitive claims are made, and a call for larger, controlled studies is emphasized throughout.
3. "The style is unclear; aim of the study is not well stated."
   Response:The study aim has been clearly articulated at the end of the Introduction and the abstract. Long or ambiguous sentences have been revised for clarity.

 

We hope that these comprehensive revisions address the reviewers’ concerns and improve the scientific rigor and clarity of our manuscript. Thank you again for the opportunity to revise and resubmit our work.

Sincerely,
Dr Federica Trovato, on behalf of all co-authors

Reviewer 2 Report

Comments and Suggestions for Authors

Introduction

-Please give references for the first sentences of the Introduction section.

-Please revise the sentences:

“…as they are subject to significant migration and often cause inflammation and infection.”

“…affecting the aesthetic appearance and quality of life of some patients who have resorted to them, sometimes permanently.”

-Citations in the Introduction start with reference number “2”. I could not find citation for reference number “1”

-Lines 41-43: “Given the unacceptable risk profile of permanent fillers, manufacturers have directed research towards biocompatible and absorbable substances that do not pose a risk to the appearance and health of patients”

Is this correct? biocompatible and absorbable substances do not pose a risk to the appearance and health of patients? Any reference?

Results

-Figures need legends including the meaning of the abbreviations

-Tables need titles and footnotes including the meaning of the abbreviations

-Graphs are presented as table instead of figure. The graphs are not clear and are difficult to visualize. Hard to read and understand the data. No legends.

-Table 3: is it a table or figure?

-Table 3: “more low”? “more high”?

-With regard to the patients’ images, were they authorized for use, and did the patients sign a consent form?

 Conclusions

The conclusions seem more like a discussion (requiring references citation)

References

The most recent references were published in 2022. No references published in 2023, 2024 2025?

Author Response

Response to Reviewers

We sincerely thank the reviewers for their insightful and constructive comments, which have significantly contributed to improving the quality and clarity of our manuscript. Below we provide a detailed point-by-point response.

 

Reviewer 2

1. "Please give references for the first sentences of the Introduction section."
   Response:Appropriate references have now been added to support the opening statements on global trends in aesthetic procedures and HA filler use.
2. "Please revise specific sentences for clarity and support with references."
   Response:The mentioned sentences have been revised for accuracy and clarity, and where necessary, supporting references have been included to substantiate the claims.
3. "Citations in the Introduction start with reference 2; missing citation for reference 1."
   Response:This referencing issue has been corrected.
4. "Clarify the claim that biocompatible substances pose no risk."
   Response:The sentence has been revised to reflect that biocompatible and resorbable fillers carry lower risksthan permanent fillers but are not entirely without potential complications. Supporting literature has been cited.
5. "Figures and tables need legends and clear labels."
   Response:All figures and tables now include legends, abbreviations are defined, and table/figure formatting has been revised for clarity.
6. "Graphs are unclear and presented as tables; please clarify."
   Response:The graphical content has been reviewed. Where graphs were misrepresented, they have been replaced.
7. "Table 3: is it a table or figure? 'More low'/'More high' wording."
   Response:Tables have been clarified and labeled appropriately. The wording has been revised to "lower frequency roughness" and "higher frequency roughness" for scientific precision.
8. "Were patients' images authorized? Was consent obtained?"
   Response:Yes, all patients signed specific consent forms for both participation and publication of anonymized images. This is now stated clearly in the Ethical Considerations section.
9. "The conclusions seem more like a discussion."
   Response:The Conclusions section has been revised for conciseness and now focuses on summarizing key findings and acknowledging limitations rather than re-opening interpretive discussion.

We hope that these comprehensive revisions address the reviewers’ concerns and improve the scientific rigor and clarity of our manuscript. Thank you again for the opportunity to revise and resubmit our work.

Sincerely,
Dr Federica Trovato, on behalf of all co-authors

 

Reviewer 3 Report

Comments and Suggestions for Authors

Thank you for submitting your manuscript titled "Evaluation of Effectiveness, Duration and Anti-Aging Properties of Sofiderm® Hyaluronic Acid Filler: An Analysis Based on VisiaCR5 Data" to our journal.

We have the following comments:

1. The introduction does not sufficiently address current gaps in knowledge regarding HA fillers, particularly Sofiderm®.
2. The hypothesis is not clearly articulated or adequately justified.
3. The limited sample size significantly weakens the strength and generalizability of the study’s conclusions.
4. The criteria used for patient selection are not clearly described.
5. Please clarify whether there were any sources of selection bias.
6. The discussion should include a more comprehensive comparison with findings from other relevant studies.
7. Statements regarding the "high corrective power" and "excellent safety profile" of Sofiderm® are not supported by comparative data or benchmarks from previous research.
8. Please expand the limitations section to provide a thorough discussion of the study’s constraints.
9. The conclusions appear to overstate the reliability of the findings given the methodological limitations, and the implications for clinical practice are not clearly defined beyond the use of technological tools as a gold standard.
10. Please indicate whether ethical approval and patient consent were obtained. Additionally, grammatical and typographical errors throughout the manuscript should be addressed and corrected.
11. Terms such as "extremely painful" or "lower than expected" are subjective; please use validated scales or provide quantitative data where possible.
12. Ensure that all tables and figures include clear legends and captions for ease of interpretation.

 

Author Response

Response to Reviewers

We sincerely thank the reviewers for their insightful and constructive comments, which have significantly contributed to improving the quality and clarity of our manuscript. Below we provide a detailed point-by-point response.

 

Reviewer 3

1. "The introduction does not sufficiently address current gaps in knowledge regarding HA fillers, particularly Sofiderm®."
   Response:The Introduction has been revised to better highlight existing gaps in the literature, particularly the lack of independent clinical data evaluating Sofiderm® fillers using objective digital tools. We have also expanded the rationale for investigating this specific product in the context of existing HA filler options.
2. "The hypothesis is not clearly articulated or adequately justified."
   Response:We have clarified the study aim and hypothesis in the final paragraph of the Introduction. Specifically, we now state that the study was designed to evaluate the clinical and instrumental efficacy, durability, and safety of Sofiderm® HA fillers in a pilot setting using high-resolution imaging.
3. "The limited sample size significantly weakens the strength and generalizability of the study's conclusions."
   Response:We fully agree. The limitations of the small sample size and pilot design are now clearly acknowledged in the revised Discussion and Conclusions sections.
4. "The criteria used for patient selection are not clearly described."
   Response:We have added detailed inclusion criteria under the Materials and Methods section: Caucasian adult patients presenting with varying degrees of photoaging (Griffiths scores 4–8), no recent aesthetic procedures, and willingness to participate and provide consent.
5. "Please clarify whether there were any sources of selection bias."
   Response:We now explicitly state in the Methods that the sample was drawn from patients consecutively treated in private practice, which may introduce selection bias. This limitation is addressed in the Discussion.
6. "The discussion should include a more comprehensive comparison with findings from other relevant studies."
   Response:The Discussion has been substantially revised to include a balanced comparison with data on other commercial HA fillers (e.g., Juvederm®, Belotero®, Teosyal®), particularly in terms of durability and safety profiles.
7. "Statements regarding the 'high corrective power' and 'excellent safety profile' of Sofiderm® are not supported by comparative data."
   Response:We have removed or softened these claims throughout the manuscript. Instead, we now frame the results as preliminaryand interpret them cautiously in light of the study design.
8. "Please expand the limitations section to provide a thorough discussion of the study's constraints."
   Response:The Limitations section has been expanded and now addresses the small sample size, lack of a control group, single-operator bias, and potential confounding factors such as weight loss and sun exposure.
9. "The conclusions overstate the reliability of the findings; implications for clinical practice are not clearly defined."
   Response:We have revised the Conclusions to reflect a more cautious tone, emphasizing the exploratory nature of the study and the need for further controlled research. The potential clinical utility of instrumental imaging is presented as a methodological advancement rather than a definitive recommendation.
10. "Please indicate whether ethical approval and patient consent were obtained."
    Response:We have added an “Ethical Considerations” section stating that all patients provided informed consent for treatment and image use. As the study involved in-label use of CE-marked fillers in private clinical practice, formal ethical committee approval was not required.
11. "Terms such as 'extremely painful' or 'lower than expected' are subjective."
    Response:These expressions have been replaced or revised to reflect more objective descriptors. Where possible, qualitative reports have been supported by clinical context or omitted.
12. "Ensure that all tables and figures include clear legends and captions."
    Response:All tables and figures have been reviewed and updated with clear, descriptive titles, legends, and explanations for any abbreviations used.

We hope that these comprehensive revisions address the reviewers’ concerns and improve the scientific rigor and clarity of our manuscript. Thank you again for the opportunity to revise and resubmit our work.

Sincerely,
Dr Federica Trovato, on behalf of all co-authors

Round 2

Reviewer 3 Report

Comments and Suggestions for Authors

The manuscript has improved. 

Author Response

We sincerely thank the Reviewer for their positive feedback and are glad to know that the revised manuscript is considered improved.