Subject’s self-assessment

Study subjects were asked to evaluate their intra-operative perceptions (IOP) immediately after their first LED treatment (T1-IOP) and immediately after their last LED session (T1 + 30 days IOP). Intra-operative treatment acceptability was considered globally good regarding all assessed subjective sensations except moderate claustrophobia (CP), slight superficial BP, and moderate skin WP, both reported immediately after the first treatment session (T1-IOP) and immediately after the last treatment session (T1 + 30 days–IOP). Moderate claustrophobic sensation was reported in 20% of subjects at (T1-IOP), and 30% at (T1 + 30 days IOP). Moderate burning sensation was reported by 40% of subjects both at T1-IOP and T1 + 30 days IOP. Similarly, 70% of treated patients experienced a warmth sensation both at T1-IOP and T1 + 30 days-IOP. Curiously, a slightly better intra-operative acceptability score regarding ‘pleasant feeling’ and ‘absence of fear’ was reported at T1 + 30 days, probably because study subjects experienced a progressive adaptation to intra-operative associated symptoms during the course of LED treatments. Of note, AOP was perceived by 100% of subjects (90% totally agree, 10% partially agree) both after the first treatment (T1-IOP) and at the end of treatment sessions (T1 + 30 days-IOP). Ninety percent of study subjects considered these treatments as high safety profile procedures (70% totally agree, 20% partially agree at T1-IOP; 60% totally agree, 30% partially agree at T1 + 30 days-IOP). Absence of fear was reported by 90% of subjects (80% totally agree, 10% partially agree) at T1-IOP, while 100% totally agree at T1+30 days-IOP. When asked to regard their sensations immediately after LED exposure study subjects reported a pleasant feeling in 40% of cases at T1-IOP and in 50% of cases at T1 + 30 days IOP.

Figure 3 Computerised facial complexion analysis (wrinkles) at T0 (immediately pre‑treatment (left)) and T45 (15 days after eight LED treatments (right))

Figure 3 Computerised facial complexion analysis (wrinkles) at T0 (immediately pre‑treatment (left)) and T45 (15 days after eight LED treatments (right))

Study subjects were asked to evaluate the sensations perceived on their skin immediately after the first treatment session (T1-END) and immediately after the last treatment session (T1 + 30 days-END) regarding PF, AOP, BP, and WP. Forty percent of subjects regarded their LED treatment as pleasant both at the end of the first session and at the end of the last session. Twenty percent of subjects considered the treatment unpleasant after the first session, while no subjects were of the same opinion after the last treatment session. Eighty percent of subjects reported a complete absence of pain, while 20% were totally indifferent both at T1-END and  at T1 + 30 days-END. With regard to BP, 20% of subjects reported a mild burning sensation immediately post-treatment at T1-END, while 40% confirmed this sensation at T + 30  days-END. IR photo-thermal burning is usually associated with a perception of deep tissue warmth and this was confirmed by 50% of subjects at T1-END and 70% at T-1 + 30 days-END.

Study subjects were further asked to evaluate the superficial perception of their skin 24 hours after the first treatment (T1-END + 24 hours) and 24 hours after the last LED session (T1 + 30  days+ 24 hours). One hundred percent of subjects totally agreed with regard to the absence of procedure-related interferences with their usual social activities (NISA = not interfering with social activities) at T1-END + 24 hours, while 90% of subjects confirmed their initial evaluation, and 10% partially agreed to it at the end of the last LED treatment (T1 + 30  days+ 24 hours). Regarding the possibility of applying their usual make-up after the procedure (NIMU = not interfering with make-up use), 90% of subjects totally agreed about the absence of any interferences induced by LED irradiation, while only 10% partially agreed with this point at T1-END + 24 hours. Ten percent of subjects disagreed with this, while 80% totally agreed and 10% partially agreed at the end of the last LED session (T1 + 30 days + 24 hours). Absence of pain was confirmed by 90% of subjects, while 10% were indifferent at the end of the first LED treatment (T1-END + 24 hours). One hundred percent of patients agreed with this perception (90% totally, 10% partially by referring a mild BP) at the end of the last treatment (T1 + 30 days + 24 hours). Absence of superficial desquamation (AOD) was perceived by 80% (totally agree) of subjects, while 10% disagreed, and only 10% totally disagreed at the end of the first LED treatment (T1-END + 24 hours). With regard to the same observation, 90% of subjects totally agreed and 10% confirmed their indifference at the end of the last LED session (T1 + 30 days + 24 hours). Absence of post-treatment redness (AOR) was confirmed by 70% (totally agree) and 20% (partially agree), while only 10% totally disagreed with this observation at the end of the first LED treatment (T1-END + 24 hours). Regarding the same point, 60% of subjects totally agreed and 30% partially agreed at the end of the last LED session (T1-END + 24 hours). The percentage of subjects who totally disagreed with this point remained the same (10%).

Subjective assessment of clinical results confirmed what was already evident after the evaluation of objective parameters considered for the study. Skin texture improvement was considered quite significant by 100% of study subjects. Overall effectiveness reported at T2 was regarded as extremely effective (40%), very effective (30%), effective (20%), and  moderately effective (10%). The same 100% effectiveness was also reported at T3 (30% extremely effective, 20% very effective, 20% effective, and 30% moderately effective). Ninety percent of subjects also considered the treatment effective in improving their wrinkles at T2. Of these, 20% considered the treatment extremely effective, 40% very effective, 20% effective, and 10% moderately effective. The same overall effectiveness percentage was registered at T3, with moderate inter-subject variations: 20% of subjects considered the treatment extremely effective, 20% very effective, 20% effective, and 30% moderately effective.

The most important improvement reported was on overall skin tone perceived by study subjects. All treated subjects considered LED photobiomodulation effective at T2 (T1 + 45 days). Fifty percent considered the treatment extremely effective, 40% very effective, and 10% moderately effective. Slight variations in the clinical evaluation score were observed at T3 (T1 + 75 days), always keeping a 100% satisfaction rate. Of these, 30% of subjects considered the treatment extremely effective, 20% very effective, 20% effective and 30% moderately effective. In spite of the opposite trend observed for superficial skin spots as measured by Visia computerised skin complexion analysis, most study subjects considered this specific parameter improved. Eighty percent of subjects confirmed an improvement at T2 (30% extremely effective, 20% very effective, 10% effective, and 20% moderately effective). Ninety percent of subjects confirmed an improvement also at T3 (30% extremely effective, 10% very effective, 30% effective, 20% moderately effective).