PEER-REVIEW | FACIAL AESTHETICS |
Figure 8 Skin erythema global value variations (standardised L + R cheek spot
measurements — median
values) and corresponding percentages of global
elastometry improvement
(L + R cheek — median values) at T1 = baseline, T2 = 15 days, and T3 = 45 days post-treatment
GLOBAL ERYTHEMA READING VARIATION
17.60 17.40 17.20 17.00 16.80 16.60 16.40 16.20
T1 17.51 16.87 16.71
5% 4% 3% 2% 1% 0%
T2 Overall clinical outcome assessment
Clinical photography assessment was performed blindly by two independent dermatologists who were asked to identify the temporal order of digital pictures taken at T1: immediately pre-treatment; T2: T1 + 45 days (15 days after the completion of eight LED treatments); and T3: T1 + 75 days (45 days after the completion of eight LED treatments), after being blindly reshuffled by a nurse. A simple percentage match was used to evaluate the magnitude of agreement between the two reviewers.
Results All ten subjects completed the full series of treatment sessions and attended all scheduled follow-up visits. No variations were detected regarding subjects’ BMI during the duration of the study (Figure 2).
Absence of pain was
confirmed by 90% of subjects, while 10% were
indifferent at the
end of the first LED treatment.
Overall clinical outcome photographic assessment by independent reviewers Both reviewers correctly identified the pre-treatment photographs (100% concordance). Moderate disagreement was registered with regard to the correct assignment of T2 (T1 + 45 days) and T3 (T1 + 75 days) images (72% concordance) (Figure 3).
Objective assessment of skin texture, wrinkles, and superficial pigment alterations Skin texture irregularities, wrinkle count, and superficial pigment irregularities were automatically evaluated using the computerised feature count system installed on a Visia Complexion Analysis unit. Computerised assessments were made immediately before the first LED treatment (T1), at T2 (T1 + 45 days), and at T3 (T1 + 75 days). Global skin texture feature count was found
significantly decreased from baseline values at T2 (-8.96%) (Figure 4) followed by a slight upward variation, keeping values still below baseline at T3 (- 6.93) (Figure 5). Global wrinkle feature count showed an even more marked decrease from baseline values at T2 (-23.23%), followed by a slight upward variation at T3 (-16.8) (Figure 6). Superficial spot feature count showed an opposite global trend scoring a +0.69% at T2 and a + 11.96% at T3 (Figure 7).
32 ❚
Erythema and elastometry Surface skin erythema showed a slight increment at T2 (+ 0.97%) followed by a more pronounced increase at T3
March 2013 |
prime-journal.com T3 GLOBAL ERYTHEMA VARIATION % 4.81%
0% T1
0.97% T2 T3
(+ 4.81%), confirming the positive metabolic stimulation of LED treated regions (Figure 8). Global elastometry showed a marked improvement at T2 (+ 20.59%) followed by a moderate decrease (+ 10.99%), keeping still above baseline values, at T3 (Figure 9).
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 10). 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
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