Evaluation of the Efficacy of IALUSET VITAL^® Cream in Helping the Improvement of the Atopic Dermatitis Symptoms in Adults: A Randomized, Double Blind, Vehicle-Controlled Clinical Trial

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The author reported that IALUSET VITAL® significantly reduced AD severity and revealed to be effective in alleviating the most common signs and symptoms of moderate AD, suppressing itch and improving skin moisturization, and to have a good safety profile, being well-tolerated by patients. 

1. The table 2 is too complicated. Please use more easily understood way to present your data.
2. In Figure 2, there is significant differences between active treatment and vehicle group "only" in SCORAD. In other parameters, no significant differences were noted between two groups. Therefore, the author should state this finding in the abstract. And the other improvement of itching sensation/moisturization may be due to vehicle cream instead of active component (hyaluronic acid and extract of Salvia haenkei).

Author Response

Response to Reviewer 1 Comments

Point 1: The table 2 is too complicated. Please use more easily understood way to present your data.

Response 1: I have realized that the submitted file had an error: in the figure legend related to Table II, most of the description was missing. Please refer to the following description included in the figure legend, in order to clarifies the data shown in Table II:

Table II. A) Scores of all parameters determined at the indicated time points according to the study design in control and active groups (median, mean and variance values are shown). B) Changes from baseline for each parameter analyzed at the indicated times in the two study groups. The median of differences was calculated as the 50th percentile of all individual differences from baseline; the mean of differences was calculated as the average of all individual differences from baseline.

Notes: in the revised manuscript, the Table II has been converted to Table III, because a new table, showing demographic characteristics, has been included.

Point 2: In Figure 2, there is significant differences between active treatment and vehicle group "only" in SCORAD. In other parameters, no significant differences were noted between two groups. Therefore, the author should state this finding in the abstract. And the other improvement of itching sensation/moisturization may be due to vehicle cream instead of active component (hyaluronic acid and extract of Salvia haenkei).

Response 2:  I have modified the abstract taking into account your suggestions. Please consider the following revision:

Abstract: Atopic dermatitis (AD) is a chronic relapsing skin disease, associated with impaired skin barrier function and characterized by poorly defined pruritic, erythematous lesions. In this study, the efficacy of a new topical cream (IALUSET VITAL®), containing hyaluronic acid and the extract of Salvia haenkei, in reducing symptoms of moderate AD in adults was investigated. This study was a randomized, double blind, vehicle-controlled clinical study. Treatment efficacy was evaluated considering both objective parameters (Scoring Atopic Dermatitis, SCORAD) and subjective pa-rameters (Patient Oriented Eczema Measure, POEM and itching sensation) and through non-invasive bioengineering techniques to measure skin moisturization and Trans Epidermal Water Loss (TEWL). Under the experimental conditions of the study, IALUSET VITAL® significantly reduced AD severity, as shown by SCORAD index and revealed to be effective in alleviating the most common signs and symptoms of moderate AD, suppressing itch and improving skin moisturization, and to have a good safety profile, being well-tolerated by patients. However, statistically significant differences between active and vehicle group were not found in the other parameters analyzed, likely because the basic formulation of IALUSET VITAL® guarantees good emollient properties and the addition of hyaluronic acid and extract of Salvia haenkei as active ingredients results in a great increase in effectiveness.

Reviewer 2 Report

Comments and Suggestions for Authors

1. 1. I recommend the authors to revise the manuscript according to CONSORT guidelines.  You may use the checklist and accordingly revise your article. (http://www.consort-statement.org/) For example, you need to clarify the randomization method, you may add a participant flow chart, and so on... 
   
   2. It would be easier for the readers to catch how effective the topical agent is, if you provide the representative photographs (agent vs vehicle, before and after treatment).

Author Response

Response to Reviewer 2 Comments

Point 1: I recommend the authors to revise the manuscript according to CONSORT guidelines.  You may use the checklist and accordingly revise your article. (http://www.consort-statement.org/) For example, you need to clarify the randomization method, you may add a participant flow chart, and so on...

Response 1: The manuscript has been revised according to the CONSORT guidelines. In particular, I have included a more detailed description in “study population, randomization and treatment” paragraph in materials and methods section, in order to clarify the randomization method and the blinding. The description is the following:

After the enrollment, a restricted randomization list was generated using PASS 11 (version 11.0.10; PASS, LLC. Kaysville, UT, USA) statistical software running on Windows Server 2008 R2 Standard SP1 64-bit edition (Microsoft, USA). The list was created by a biostatistician and stored in a safe place. The randomisation sequence was stratified using ‘Efron’s biased coin’ algorithm with a 1:1 allocation ratio. Participants were randomized into 2 groups: the active group applied the IALUSET VITAL® cream and the control group applied the vehicle cream (Figure 1 A).

The study adhered to established procedures to maintain separation between the investigator and its collaborators and the staff that delivered the intervention. Investigator and its collaborators who obtained outcome measurements were not informed on the product group assignment. Staff who delivered the intervention did not take outcome measurements. Subjects, investigator and collaborators were kept masked to products assignment.

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

I think that the article is improved now.