Striae Distensae and an Innovative Intradermal Medical Device Based on PN HPT™, Hyaluronic Acid, and Mannitol. A Real-World Insight

Introduction: Striae distensae are often more than a mere skin aesthetic trouble for their impact on self-esteem and as signals of internal medicine disorders like hypercortisolism or cachexia. There is a need to advance in treating striae distensae effectively, particularly their late atrophic hypochromic stage. PN HPT™ may help to restore and preserve a physiologically sound dermal environment. The paper reports the outcomes of a survey study based on an anonymous questionnaire. The study’s purpose was to confirm the long-term effectiveness and safety profile of an intradermal medical device based on PN HPT™ (1 mg/mL), HA (1 mg/mL), and mannitol ) within a multi-year clinical monitoring program. Methods: The investigators — dermatologists


Introduction
Improving the aesthetics of the impervious forms of dermal scarring known as striae distensae has been a medical challenge since the first histological description in 1889 [1].
The treatment challenge does not ease following the progressive fading of the earlier, inflamed erythematous and violaceous striae rubrae into the finely wrinkled and atrophic dermal scar-like lesions known as striae albae.Unfortunately, the striae albae problem, prevalent in epidemiological studies between 11% and 88%, is extensive in the general population.
It is not simply a problem of adolescents fearful of peers' judgment or young pregnant women unsatisfied with their self-image or physical appearance [2].
The words of a recent paper about the adverse impact of striae distensae, either erythematous or atrophic, on adolescents 9-12 and 13-16 years old leave no doubt-" (striae distensae) should not be considered only as a cosmetic problem" [3].
The psychosocial impact is severe, as measured by the Children's Dermatology Life Quality Index (CDLQI) and does not differ in the two adolescent age groups investigated in the study, with median total scores of only 7 out of a maximum score of 30 in younger adolescents and 6 in the 13 to 16 age group [3].
The emotional and psychological impact on pregnant women is much like that on adolescents, with the midwifery care effort to prevent striae gravidarum through moisturizing measures correlating with the emotional impact scores

Based on spontaneous reporting by cohort individuals and
open questions in the questionnaire, the purpose was to identify known side effects and describe their presentation and severity using an impromptu three-score qualitative scale ("mild", "moderate", and "severe"), and identify any previously unknown adverse event or emergent risk.The investigator complemented the individual spontaneous reports by actively questioning for adverse events at the final assessment visit.Reporting: as percent of subjects.

Statistics
The sample size was estimated using the G*Power statistical program version 3.14.The sample size calculation assumed a conservative 40% improvement in the mean investigator's GIS score after the treatment cycle.Under this assumption, the statistical power to detect a two-tailed significant

Results
Table 3 illustrates the surveyed subjects' demographics and the topographic distribution of the 38 treated striae.
Figure 1 shows the cohort's distribution of infiltration techniques.According to the clinicians who performed the study (Figure 2), 97% of the striae improved more than 25% compared with baseline, while 47% of the atrophic lesions had an improvement higher than 50%.Only a few subjects (2.6%) had a minimal improvement; no surveyed subject experienced a clinical worsening of his striae distensae.
According to the independent evaluator (Figure 3), the overall outcome was similar but slightly more conservative for the highest degree of improvement (χ 2 test for the outcome distribution between investigators and the independent evaluator: p <0.05).However, the improvement was judged superior to 25% for 100% of the evaluated striae distensae, with no striae distensae classified as "minimally improved".

Table 1 .Table 2 .
photographs documenting the baseline situation before the first therapy session and the skin changes two to four weeks after the end of the treatment cycle.Semi-quantitative assessment: based on the five-score quartile Global Improvement Scale (GIS, Table 1), developed in 2010 to evaluate the effect of laser treatment of striae distensae and used in several clinical studies on striae distansae [18,19].Secondary efficacy endpoint: Overall improvement in skin appearance two to four weeks after the last NEWEST ONE therapy session compared to pre-treatment, subjectively assessed by the investigator and self-assessed by the surveyed subject, using the five-score quartile Global Aesthetic Improvement Scale (GAIS, Table 2) [20].
improvement and minimize the ß-risk of false-negative type II errors would have been greater than 0.92 with a sample of 34 striae distensae [22].Inferential statistics was limited to compare the mean investigator's and independent evaluator's GIS score distribution at the end of the follow-up period (2x2 χ 2 test for proportions with 5% significance level; statistical program: StatPlus release v7) [23].

Figure 1 .
Figure 1.Techniques used for intradermal injections in surveyed subjects.

Figure 2 . 6 Figure 3 .
Figure 2. Percent distribution of mean GIS scores (descriptors on the abscissa) according to investigators.

Figure 4 and
Figure 4 and Figure 5 show the GAIS scores for the clinicians who performed the treatment and the treated subjects, respectively.There was no objective or subjective worsening in the dermal scarring areas.Conversely, all lesions improved or much improved objectively and subjectively at the final follow-up visit, with the treated subjects especially satisfied (57.1% rating the outcome as much improved).Figure 6 illustrates three representative

Figure 6
illustrates three representative examples of the skin quality benefits foreseeable after a NEWEST ONE treatment of mature striae distensae located on the abdomen (A and B) and the arm (C).Another NEWEST ONE cycle of therapy was suggested to one subject to consolidate and further improve the benefits she had obtained.The NEWEST ONE treatment was well tolerated, with no previously unknown adverse events and mild and transient minor side effects only at the injection site with no need for treatment-erythema in four subjects and bruising and pain at the injection site in two subjects, respectively.No subjects reported ulceration, suppuration, keloid formation, recurrence, or other severe side effects.All side effects resolved at most in a few hours; only an episode of bruising lasted for five days.

Figure 4 .
Figure 4. Percent distribution of mean GAIS scores (descriptors on the abscissa) according to the clinicians who performed the treatment (investigators).

Figure 5 .
Figure 5. Percent distribution of mean GAIS scores (descriptors on the abscissa) according to the self-assessment by treated subjects.

Figure 6 .
Figure 6.Representative examples of the aesthetic benefits foreseeable with NEWEST ONE.Pictures published with the subject's written agreement.Courtesy of Isabella Pia Palmieri.

Table 3 .
8 ± 11.85 Demographics of the subjects surveyed after treatment with NEWEST ONE.SEM = standard error of the mean