NCTF®135 HA is a polyrevitalizing solution (PRS) composed of hyaluronic acid, amino acids, vitamins [13], coenzymes, nucleic acids, minerals, and antioxidants. It is designed to promote dermal hydration, stimulate fibroblast activity, and improve overall skin quality. ART FILLER Universal® is a specific combination of different crosslinked hyaluronic acid containing 0.3% by weight of lidocaine hydrochloride for its anesthetic properties.

This is an Investigator Initiative Trial on six subjects presenting rolling-type acne scars of moderate to severe grade (score ≥ 2). All participants signed a written consent form and underwent a single full-face treatment session using a combination of ART FILLER® Universal (Fillmed Laboratories, France) and NCTF® 135HA (FILLMED Laboratories, France). A local anesthetic injection was performed to the entire zone prior to the procedure. All injections were performed under sterile conditions by the same physician.

Subcision was performed using an 18 G Nokor needle to release fibrotic scar bands. Injections were then carried out with a blunt-tip cannula, following the BioNutriLift™ technique. HA Filler was first injected into the mid to deep dermis for volume restoration, followed by Polyrevitalizing solution into the dermis and subdermis to break the under-scar fibrosis while promoting the bio-stimulation and improving skin healing and quality. Products were injected locally in acne-scar areas through the same entry points (Figure 1). Product depth and quantity adjusted according to individual topography. Follow-up assessments were conducted at Day 180 (6 months) post-treatment to evaluate safety, tolerability, and clinical outcomes.

Figure 1. Representative scheme of injection sites within subject skin. Subcision was performed to release fibrotic scar bands. HA Filler was first injected into the mid to deep dermis for volume restoration, followed by NCTF into the dermis and subdermis to break the under-scar fibrosis.

The 2 females and 4 males subjects were enrolled for this study, with a mean age of 29-year-old. Their individual characteristics were summarized in Table 1. Participants were screened for eligibility before enrollment in order to reduce confounding factors and improve reproducibility.

Inclusion criteria:

Adults aged 18 years or older;Presence of clinically visible post-acne scars of the face considered appropriate for treatment with subcision;Stable acne scar burden at baseline, with scars present for at least 6 months before enrollment;No active inflammatory acne requiring systemic therapy at the time of inclusion, or only minimal/residual acne activity not expected to interfere with scar assessment;Willingness to avoid initiation of new scar-directed procedures, topical regimens, or systemic acne treatments during the study period;Ability to comply with the study visits, treatment sessions, and follow-up assessments.

Table 1. Baseline participant characteristics (age, sex, Fitzpatrick phototype, scar location distribution, baseline scar severity range, and concomitant skincare/medications).

Exclusion criteria:

Predominantly active inflammatory acne, acne conglobata, or other active facial dermatoses that could interfere with evaluation;Hypertrophic scars or keloid tendency;Facial infection, herpes simplex outbreak, or other local condition at the treatment site at baseline;Known hypersensitivity to any component of the injected product;Coagulation disorders, use of anticoagulants or antiplatelet medication that could increase procedural risk;Pregnancy or breastfeeding;History of autoimmune disease, uncontrolled systemic disease, or impaired wound healing, where relevant to procedural safety;Use of isotretinoin within the predefined washout period;Any prior scar treatment within the predefined washout period likely to affect baseline appearance or outcome assessment;Participation in another interventional clinical study during the study period.

Active acne status was documented at baseline. Participants with moderate-to-severe active inflammatory acne were excluded in order to avoid confounding from ongoing inflammation and concurrent treatment needs. Participants with absent, minimal, or clinically stable acne activity could be included, provided that acne severity was not expected to significantly influence scar outcome assessments.

The 5-point Acne Scar Assessment Scale (ASAS), rated by both physician and subjects, was evaluated at baseline and at D180 [14].

Acne Scar Improvement Score, adapted from the scale described by Dierickx et al. [15], was also used to evaluate categorized improvement based on percentage change from baseline.

The Global Aesthetic Improvement Scale (GAIS) from both injector and subjects’ perspective using a 5-point scale was determined and recorded.

Finally, a VISIA® photography was performed before the intervention and 180 days post-injections using a standardized high-resolution facial imaging.

Clinical evaluations were based on validated scales and included both investigator-reported and patient-reported outcomes. Physician-rated ASAS scoring was performed by an independent evaluator. Standardized VISIA® imaging was conducted under consistent lighting and positioning conditions.

Descriptive statistics were used for baseline characteristics. Changes from baseline were analyzed using Wilcoxon signed-rank tests. A p-value < 0.05 was considered statistically significant. In addition to p-values, mean changes with 95% confidence intervals (CI) were calculated to better characterize the magnitude and precision of treatment effects. Given the small sample size (n = 6), these estimates should be interpreted as exploratory. No formal adjustment for multiple comparisons was applied.

At Day 180 post-injection, acne scar severity was evaluated by an independent physician using the 5-point Acne Scar Assessment Scale (ASAS) as described by Munavalli et al. [14]. As shown in Figure 2(A), treatment with injections led to a statistically significant reduction in acne scar severity. The mean ASAS score decreased from 2.83 to 1.33, corresponding to a mean change of −1.50 (95% CI: −2.38 to −0.62; p = 0.008).

Figure 2. Mean Change in ASAS Score from Baseline to D180. (A) Physician evaluation in ASAS, Clear = no depression, Very mild = a single depression, Mild = few to several depressions detectable with direct lighting, Moderate = more than half of depressions are apparent, Severe = all lesions can be seen; (B) Subjects cheek appearance grading by the subject self-assessment (Baseline vs D180). **p < 0.01; ***p < 0.001 D0 vs. D180.

The clinical improvement was supported by subject-reported outcomes using a Self-Assessment Scale (Figure 2(B)), which showed a significant improvement in subject satisfaction, from a mean score of −1.33 (Dissatisfied) at baseline to +1.17 (Satisfied) at Day 180 corresponding to a mean change of +2.50 (95% CI: +1.93 to +3.07; p < 0.001).

Treatment efficacy was further evaluated using an adapted Acne Scar Improvement Score derived from the method of Dierickx et al. [15]. The average improvement score increased significantly from 0 (No improvement) at baseline to 2.83 (Good improvement) at Day 180, mean change of +2.83 (95% CI: +2.04 to +3.62; p < 0.001) (Figure 3(A)). Among the six enrolled subjects, four demonstrated an improvement of at least three grades, while the remaining subjects showed a two-grade improvement.

To further demonstrate the treatment benefits, subject full faces were photographed before and 180 days after the injections (Figure 3(B)). Standardized photos showed visible reductions in scar depth, smoother contours, and more uniform skin texture. These visual outcomes correlated well with both subjective and objective measures.

Both physician and subject satisfaction levels were evaluated using the 6-point Global Aesthetic Improvement Scale (GAIS). As shown in Figure 4, the injector-

Figure 3. (A) Mean change in Acne Scar Improvement Score from Baseline to D180. Minimal = improvement < 25%, Moderate = improvement 25 - 49%, Good = improvement 50 - 74%, Very good = improvement > 75%; ***p < 0.001 D0 vs. D180; (B) VISIA Imaging comparison pre- and post-Treatment of two representative subjects.

assessed GAIS score demonstrated a significant improvement of 2 grades between Day 0 and Day 180, mean change of −1.83 (95% CI: −2.26 to −1.40; p < 0.001). Specifically, five subjects were rated as having achieved “moderate improvement”, and one as “minimal improvement” (Figure 4(A)). Notably, self-assessments revealed an even more pronounced perception of benefit, with an average improvement of 3 grades at Day 180 mean change of +3.17 (95% CI: +2.74 to +3.60; p < 0.001) (Figure 4(B)). Four subjects rated their outcome as “good improvement”, and one reported a “very much improved” result. No subjects rated their results as unchanged or worse.

Figure 4. Mean change in Injector (A) and Patient (B) Global Aesthetic Improvement (GAIS) Ratings at D0 and D180 post-injections. ***p < 0.001 D0 vs. D180.

Treatment tolerability was evaluated through systematic collection of solicited and unsolicited adverse events at each study visit. Solicited reactions included pain, erythema, edema, bruising, tenderness, pruritus, and palpable irregularities. Each event was characterized by severity, duration, and any management required. Unsolicited adverse events were also documented throughout follow-up.

Particular attention was given to nodules, vascular events, pigmentation changes, prolonged edema, infection, and any worsening of scar appearance. Overall tolerability was determined based on the incidence, severity, and resolution of these events.

4 out of 6 patients report transient edema and erythema at treatment site, lasting 2 - 4 days. 3 patients report bruising at treatment site, lasting 8 days to full resolution. No unsolicited adverse events were reported.