Protective labial gel with OGT. ACURA is a protector and covering gel indicated in the symptomatic treatment of labial herpes. ACURA covers the fever blister with a protector invisible film. So doing, it protects and facilitates the healing process. From the first day of treatment, ACURA has a positive effect on painful symptoms of herpes. As for second intention, positive results were evident on clinical signs. The efficacy of ACURA has been demonstrated in a comparative clinical study against placebo.

Clinical study

Study title

CARIL/001/08 ‘’Evaluation of the efficacy and safety of CS 20 protective barrier gel compared to placebo on symptoms of herpes labialis’’

InvestigatorS

Prof. Jean-Paul Ortonne, Head of Clinical Department, Dermatologist, University hospital center l’Archet 2 – F - 06200 Nice

Study design

Single-centre study, conducted by a single-blinded investigator versus placebo in 2 parallel groups of 35 subjects; this study is part of the CE marking.

Study procedure

2 phases :
- An eligibility period lasting a maximum of 6 months during which recurrence of herpes labialis must occur.
- A treatment phase after onset of symptoms
Screening visit: the investigator checks that the patient satisfies all of the inclusion and does not present any exclusion criteria.
Eligibility period: Following the screening visit, patients should experience a recurrence of herpes labialis during the 6 month eligibility period. As soon as the patient experiences the first symptoms of recurrent herpes labialis, they must consult the investigator within 36 hours.
Treatment phase : Visits at J1, J2, J3, J8 and J15

Primary endpoint:
- Intensity score of subjective symptoms (burning, pain, itching, prickling and their sum) evaluated by the subject on a visual analogue scale (VAS)

Results/Conclusions

PERCENTAGE OF REDUCTION OF THE PAIN SCORE COMPARED TO BASELINE (D1) (EVA scale 100mm)

PAIN SCORE

PUBLICATION

Article

Evaluation of the efficacy and safety of a CS20 protective barrier gel containing OGT compared with placebo on functional and objective symptoms of labial herpes recurrences : a randomized clinical trial.

Authors

A . Khémis, Luc Duteil, A.C. Coudert, Y. Tillet, O. Dereure, J.P. Ortonne

JOURNAL

JEADV : Journal of the European Academy of Dermatology and Venereology – 2011