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96 WUNSCH AND MATUSCHKA after t30 + 6 months using 10 cm VAS for the improvements in skin complexion and skin feeling. These parameters were not assessed in the control group. Objective clinical parameter assessment The high-resolution ultrasound examination of collagen has enabled the measurement of visible changes in collagen density and numerical CISs representing the intradermal collagen fiber density. Profilometry yielded a numerical va- lue for the Ra of the skin area under examination. Investigator assessment Three independent physicians who were blinded to the clinical patient data, analyzed the clinical photographs ob- tained at t0 and t30. The investigators were instructed to arrange the randomly assorted sets of clinical photographs taken at t0 and t30 into a before/after treatment sequence. The baseline wrinkle depth according to the Modified Fitz- patrick Wrinkle Scale (MFWS)12 and the degree of wrinkle reduction after treatment had to be assessed after sequenc- ing. The votes of the investigators were summarized by the following majority rules: if two or three experts voted the same way, the agreed-upon classification was the summary measure; if all three experts voted differently, ‘‘no change’’ was the summary measure. Statistical methods The data in the tables are given as means–standard deviations. Comparisons of the changes in skin feeling, skin complexion, roughness, and collagen intensity from the baseline to t30 between the different treatment groups (in- tergroup comparisons) were performed using a linear model, with the baseline value of each volunteer as a covariate. Within-group differences from the baseline to values at t30 were assessed using the Mann–Whitney–Wilcoxon test. To compare wrinkle difference assessments among groups, we used the v2 test. Within groups, we tested the hypothesis of equal probabilities of improvement and worsening using binomial tests. All tests were two sided, and p values < 0.05 were considered statistically significant. Results Patient characteristics Initially, 144 volunteers were recruited for the trial. Eight volunteers did not appear for the first appointment after randomization; therefore, the total number of patients finally included in the study was 136. Five volunteers stopped participating because of schedule incompatibilities and lack of time. One volunteer could not finish the treatment because of receiving antibiotic medication, which was one of the ex- clusion criteria; one volunteer terminated participation be- cause of moving away; and one participant missed more than four treatments because of a period of residence at a health resort. Ultimately, 128 volunteers completed the treatment and the follow-up evaluation course, of whom 57 were treated with RLT, 48 were treated with ELT, and 23 were controls. The volunteers in the RLT and ELT groups were similar with respect to age, weight, skin complexion, skin feeling, skin roughness, and intradermal collagen density. The percentage of women was lower in the ELT group than in the RLT group. The controls had a slightly higher mean collagen density and a lower mean skin roughness. Adverse events None of the volunteers dropped out because of an adverse event. No severe adverse events were registered during the study or the follow-up phase. One volunteer with facial telangiectasia noticed an increased visibility after the first treatments, and decided to protect the zones in question from the light influence using a concealer for the rest of the treatment series. One volunteer experienced a reddening of scar tissue from a 40-year-old knee injury that was likely reactivated by the ELT 30 treatment. The affected scar healed completely within 1 week, and the treatments were contin- ued without interruption. Assessment of effects Figure 2 shows two series of collagen ultrasonography scans, demonstrating the collagen density increase from t0 to t30 for one subject each in the RLT group and the ELT group. Clinical photography revealed visible changes in wrinkles and skin roughness. Figure 3 shows an example for one FIG. 2. Collagen ultrasonography examples.PDF Image | Trial to Determine the Efficacy of Red Near-Infrared Light Treatment
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