RESULTS
Therapy combinations were tailored according to the individual patient´s
response to previous treatments, health condition, and current wishes.
In half of the cases, patients were not eligible to standard doses of
isotretinoin due to previous discontinued therapy caused by severe
adverse effects, including dryness of skin, elevated levels of creatine
phosphokinase (CPK) or transaminase, worsening of symptoms, or preceding
disease history (Figure 1A-D). Furthermore, most patients had previously
been treated with tetracycline and topical therapeutics without effect.
These patients were in this trial treated with FLE in combination with
low-dose isotretinoin alone or for some female cases together with
contraceptives. Substantial improvements in acne symptoms were observed
in all six patients already at week 6 after treatment was initiated with
further gradual clearance throughout the trial and complete clearance at
week 52 (Figure 1A-D).
A group of non-responders to tetracycline and topical treatments was
treated with FLE in combination with low-dose isotretinoin (Figure 2 and
3A). In these patients a similar gradual clearance was seen throughout
the treatment and observation time. Especially a marked progressive
reduction in inflammation was observed (Figure 2 and 3A).
Finally, three patients with moderate acne symptoms were treated with
FLE combined with tetracycline. For these patients previous treatment
using topical or standard dose tetracycline or isotretinoin regimes
failed. Although substantial improvements were observed for all three
patients, few papules and comedones remained and complete clearance was
not obtained (Figure 3B-D).
Taken together, all patients showed substantial improvements in the
clinical appearance of the skin already at week 6 after treatment was
initiated (Figure 4A). In 50% of the cases, patients showed a marked
enhancement quantified by a 2-grade improvement according to the IGA
scale, whereas the remaining 50% presented with a 1-grade decrease
according to the IGA score (Table III). At the week 12 evaluation, 75%
of patients showed a reduction in clinical severity to IGA 1. The
remaining 25%, showed improvements corresponding to 1- to 2-grade IGA
reduction although maintaining IGA scores of 2-3. Interestingly, at the
evaluation at week 33 and 52 patients treated with FLE in combination
with isotretinoin reached and maintained an IGA score of 0 at week 33
and 52, whereas the three patients treated with FLE combined with
tetracycline presented an IGA score of 1 (Table III).
At the final evaluation at week 52, patients evaluated satisfaction with
the clinical outcome and the treatment as a whole. All patients reported
high satisfaction rates with the treatment results. Overall, 75% of
subjects were very satisfied and 25% satisfied with the treatment
outcome (Figure 4B). Thus, we found a substantial association between
IGA-rated improvement and patient satisfaction.
Adverse effects related to the treatments were assessed after each FLE
session by the patients evaluating and reporting. Overall, no severe or
intolerable adverse effects were reported (Figure 4C) and no patients
discontinued the study. In line with previous clinical
studies,15,16 a few patients reported that FLE
treatment induced transient erythema (lasting no more than 36 hours),
temporary skin hyperpigmentation or a slight sensation of burning during
the session (Figure 4C). The most reported side-effects related to the
systemic therapy, including dryness of skin and mucosae in patients
taking isotretinoin and transient abdominal swelling (lasting a few
days) in patients on tetracycline (Figure 4C).