Effectiveness of a Complex Antioxidant Product Applied by Sonophoresis and Micro-Needle Mesotherapy

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The manuscript by Anna Jaros-Sajda et al. demonstrates a cosmetic effect of an antioxidant mixture applied by sonophoresis and microneedle mesotherapy.

The manuscript is clear presented and well written and can be accepted for publication in the journal Cosmetics after clarification of the following minor points:

1. Line 31: references 7 and 8 do not support the statement about the negative effects of IR on the skin. Please provide the correct reference(s).

2. Lines 31-32: Please provide a reference confirming the statement that vitamin C is a most potent AO. This statement needs clarification - in which skin layer. If the authors mean the viable epidermis or dermis, why are the enzymatic AOs not mentioned? If the authors mean the stratum corneum - the role of fat-soluble AOs seems to play a crucial role (see a recent review: DOI: 10.3390/antiox11081451). Please add a clarification and confirm your statements with relevant references.

3. Figure 1: the left and right sides do not match the description (lines 81-82) and seem to be opposite.

4. Line 134: “they” should be replaced with “their”.

5. The section “Materials and Methods” should be divided into subsections such as: “Volunteers”, “Applied formulation”; “Sonography”, “Mesotherapy”, “Study design”, “Skin measurement methods”, “Statistics” for better readability.

6. The subsections “Sonography” and “Mesotherapy” should be supplemented with information on the procedure used: Treatment time, frequency, power, pressure, area treated, microneedle diameter, etc. Information from the Introduction (line 72) should be moved here. What penetration depth is determined (expected) for microneedles (at what pressure)?

7. Line 161: the first sentence should be moved to the section “Materials and Methods”.

8. The authors now use the terms “volunteers”, “probands”, “subjects”, and “patients” to describe individuals. Please be consequent.

9. Results: I recommend rounding up to whole numbers, i.e., 16 and 27% instead of 15.6 and 27.2%.

10. Line 236: in our study, the word “study” is missing.

11. Please delete line 373.

12. Due to occlusion, topical cosmetics can reduce TEWL values. Were the volunteers instructed not to use cosmetics (sunscreen) on their face at least one day before the measurements? If not, this should be noted as one of the limitations of the study.

 

13. Please add whether erythema intensity increased temporarily immediately after the sonography and mesotherapy procedures, and if so, how long it takes until it levels off (microneedles destroy blood vessels). Please also explain why TEWL does not increase after microneedling.

Author Response

Please see the attachment

Author Response File: Author Response.docx

Reviewer 2 Report

Comments and Suggestions for Authors

The study has an interesting approach since it applied two different techniques, mesotherapy and sonophoresis, to evaluate the effects of antioxidants in combination on the skin. However, it is mandatory to have a control group, so that the results can be better discussed and the contribution of the study better demonstrated, since there are many effective cosmetic products containing ascorbic acid for the improvement of skin aging conditions, such as skin hydration, uniformity and viscoelasticity.

Author Response

Dear Revieweer,

Thank you for you revision.

We did not planned control group, because the idea was to compare the results before and after the cosmetic procedure. Also we did the half face test, so it would be difficult to find extra control place, because e.g. neck or other parts of the body has a little different skin parameters.

Kind regards,

Authors.

 

 

Review 2

The study has an interesting approach since it applied two different techniques, mesotherapy and sonophoresis, to evaluate the effects of antioxidants in combination on the skin. However, it is mandatory to have a control group, so that the results can be better discussed and the contribution of the study better demonstrated, since there are many effective cosmetic products containing ascorbic acid for the improvement of skin aging conditions, such as skin hydration, uniformity and viscoelasticity.

Author Response File: Author Response.docx

Reviewer 3 Report

Comments and Suggestions for Authors

Dear Authors,

I write you in regard to your manuscript entitled "Effectiveness of a complex antioxidant product applied by sonophoresis and micro-needle mesotherapy".  

- please, consider revising the abstract highlighting the gap in this context and justifying the sonophoresis and microneedle.

- lines 23-28 must be revised to achieve better understanding.

- in lines 49-50, please, consider consulting references from the last 10 years. For instance, https://doi.org/10.1016/j.jphotobiol.2018.05.026 determined the SPF in vivo of a sample containing ferulic acid. You will find more in vivo data about ferulic acid involving the anti-inflammatory property.

- please, explain the mechanism described in the line 65.

- lines 66-68 could be in another section of your manuscript.

- please, revise the objectives.

- the composition of the formulation seemed confusing. Was this sample a commercial product? Please, explain this composition.

- lines 101-130 sounded confusing. They are not methods, i.e., they are descriptions of the devices.

- how was the protocol use of sunscreens? This part of the protocol certainly interfered with the clinical assays.

- It was not clear what was the control, i.e., the formulation without actives. Please, explain it in Material/Methods.

- how many weeks of treatment the participants had?

- the use of sunscreens could have improved the TEWL.

- lines 239-240 are too speculative since there were no samples with the isolated compounds.

- the graph for the viscoelastic property was missed.

- in conclusion, please correct the line 350. according to the results, there were adverse events.

Overall, the manuscript must be deeply revised. All results must be described and a section on limitations and strengths would be welcome. 

Author Response

Dear Reviewer,

Thank you for your effort to review our paper.

We tried our best to improve our paper. Please find the answers in the text below, and in color in the manuscript.

In case of any other questions, we are interested in improving our article.

Kind regards,

Authors.

 

 

Dear Authors,

I write you in regard to your manuscript entitled "Effectiveness of a complex antioxidant product applied by sonophoresis and micro-needle mesotherapy".  

- please, consider revising the abstract highlighting the gap in this context and justifying the sonophoresis and microneedle.

The information was added.

- lines 23-28 must be revised to achieve better understanding.

The text was revised.

- in lines 49-50, please, consider consulting references from the last 10 years. For instance, https://doi.org/10.1016/j.jphotobiol.2018.05.026 determined the SPF in vivo of a sample containing ferulic acid. You will find more in vivo data about ferulic acid involving the anti-inflammatory property.

The information was added.

- please, explain the mechanism described in the line 65.

The effects of microneedling was also proven by histometry and quantitive evaluation of collagen, elastin and tropoelastin (El-Domyati M, Barakat M, Awad S, Medhat W, El-Fakahany H, Farag H. Multiple microneedling sessions for minimally invasive facial rejuvenation: an objective assessment. Int J Dermatol. 2015 Dec;54(12):1361-9. doi: 10.1111/ijd.12761. Epub 2015 Jun 20. PMID: 26096653)

- lines 66-68 could be in another section of your manuscript.

According also to the suggestions of the second Reviewer some information from this paragraph was implemented to the material and methods.

- please, revise the objectives.

The text was revised and shortened.

- the composition of the formulation seemed confusing. Was this sample a commercial product? Please, explain this composition.

It was a commercial product. We were looking for a  cosmetic that not only contain vitamin C, but also other antioxidants.

- lines 101-130 sounded confusing. They are not methods, i.e., they are descriptions of the devices.

According also to the suggestions of the second Reviewer the text was reorganized.

- how was the protocol use of sunscreens? This part of the protocol certainly interfered with the clinical assays.

The volunteers were instructed to use sunscreens every day, except the day of measurements, at the beginning of the study, and also at the end of the study, to try to organize the same skin condition to measure.

- It was not clear what was the control, i.e., the formulation without actives. Please, explain it in Material/Methods.

There was no control group, the results after the procedure were compared to the results obtained before the procedure.

There was also no formulation  without the active components

The information was added to the text.

- how many weeks of treatment the participants had?

Every participant has six procedures every second week. And the last measurement was done two weeks after the last procedure.

The information was added to the text.

- the use of sunscreens could have improved the TEWL.

The volunteers were instructed to use sunscreens every day, except the day of measurements, at the beginning of the study, and also at the end of the study, to try to organize the same skin condition to measure.

- lines 239-240 are too speculative since there were no samples with the isolated compounds.

Yes, you are right. We did not have samples with isolated compounds, so the sentense was changed.

- the graph for the viscoelastic property was missed.

We not intended to place in the text the graph, because the results were not statistically significant. But if you think it could improve our paper, we can prepare a graph.

- in conclusion, please correct the line 350. according to the results, there were adverse events.

You are totally right. We were thinking about important or long lasting ones, but it was implemented in the text. The information was added to the text.

Overall, the manuscript must be deeply revised. All results must be described and a section on limitations and strengths would be welcome. 

We tried our best to revise the text. The limitations section was added.

 

Author Response File: Author Response.docx

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

The authors improved the introduction and methods. In addition, they included the limitations of the study in the manuscript: "Finally, our study has potential limitations. Firstly, there could be greater group of volunteers. There is also no control placebo group."

Author Response

Thank you for your kind comments

Reviewer 3 Report

Comments and Suggestions for Authors

Dear Authors,

Thank you for improving your manuscript. My final comments are:

- in methods, the description of the probes does not fit this section. just describe the protocol.

- please, add the graph of the viscoelastic results.

- please, discuss the lack of a control group and the absence of the blank formulation. use references in which the protocol had a similar design to corroborate your investigation. this is a mandatory issue to add value to your work.

- limitations and strengths were poorly elaborated. please, rewrite them. 

Author Response

Dear Reviewer,

Thank you for your effort to review our paper.

We tried our best to improve our paper. Please find the answers in the text below, and in color in the manuscript.

In case of any other questions, we are interested in improving our article.

Kind regards,

Authors.

 

 

Dear Authors,

Thank you for improving your manuscript. My final comments are:

- in methods, the description of the probes does not fit this section. just describe the protocol.

We made corrections in the article.

- please, add the graph of the viscoelastic results.

The tables were added.

- please, discuss the lack of a control group and the absence of the blank formulation. use references in which the protocol had a similar design to corroborate your investigation. this is a mandatory issue to add value to your work.

The placebo group could be understand in two ways. Firstly adding a group with no cosmetic or the blank cosmetic, could add the value to our paper of the effect of only the method of application to the skin. Secondly the placebo group could use only cosmetic topically with no special application method. The face skin is quite specific in our body, because of the all year impact of external factors, we did not decide to add extra places of body skin to our protocol. We controlled our postreatment results to before treatments ones.

In cosmetic industry, opposite to drugs, there are many papers with no placebo group. The other authors compare two products on the  same person, or even topical drug and cosmetic as randomized acne patients but with no placebo.

The examples of not haning placebo group are below.

Tempark T, Shem A, Lueangarun S. Efficacy of ceramides and niacinamide-containing moisturizer versus hydrophilic cream in combination with topical anti-acne treatment in mild to moderate acne vulgaris: A split face, double-blinded, randomized controlled trial. J Cosmet Dermatol. 2024;23:1758-1765. doi:10.1111/jocd.16212

Goberdhan L, Schneider K, Makino ET, Bautista A, Mehta RC. Efficacy and safety of novel topical pigment-correcting regimen with biweekly diamond tip microdermabrasion procedures on facial hyperpigmentation. J Cosmet Dermatol. 2024;23:1726-1733. doi:10.1111/jocd.16192

Crocco EI, Torloni L, Fernandes PB, et al. Combination of 5% cysteamine and 4% nicotinamide in melasma: Efficacy, tolerability, and safety. J Cosmet Dermatol. 2024;23:1703-1712. doi:10.1111/jocd.1618

Parvizi MM, Saki N, Samimi S, Radanfer R, Shahrizi MM, Zarshenas MM. Efficacy of castor oil cream in treating infraorbital hyperpigmentation: An exploratory single-arm clinical trial. J Cosmet Dermatol. 2024;23:911-917. doi:10.1111/jocd.16056

Dal Belo SE, Kanoun-Copy L, Lambert C, et al. Efficacy of a multitargeted, salicylic acid-based dermocosmetic cream compared to benzoyl peroxide 5% in Acne vulgaris: Results from a randomized study. J Cosmet Dermatol. 2024;23:891-897. doi:10.1111/jocd.1605

Mario Puviani: Efficacy and Skin Microbiome Modulation Effects of a Fixed-Concentration Combination of Benzoyl Peroxide 4% Plus Niacinamide 4% in a Film-Forming Cream in Subjects with Mild-to-Moderate Acne: A Non-Sponsored, Prospective, Assessor-Blinded, Pilot Trial ; Cosmetics 2024, 11(1), 25; https://doi.org/10.3390/cosmetics11010025

- limitations and strengths were poorly elaborated. please, rewrite them. 

The limitations were rewirted.

 

Author Response File: Author Response.docx

Round 3

Reviewer 3 Report

Comments and Suggestions for Authors

Dear Authors,

Thank you for the revised version of your manuscript.

Comments on the Quality of English Language

English requires revision (for example, line 25).