Indication: Symptomatic treatment of genital herpes.
Protective genital gel with OGT
RD2 is a protector and covering gel indicated in the symptomatic treatment of genital herpes.
RD2 covers the herpetic lesions with a protector invisible film. So doing, it protects and facilitates the healing process.
From the first day of treatment, RD2 has a positive effect on painful signs and symptoms of herpes. The efficacy of RD2 has been demonstrated in a comparative clinical study against placebo.
RD2 (results scientifically proven) :
- Relieves significantly the painful symptoms of genital herpes as the first day of application.
- Relieves the other symptoms of genital herpes (pruritis, itching, burning) as the first day of application.
- Reduces the time to cure
CARIL/001/08 ‘’Evaluation of the efficacy and safety of CS 21 protective barrier gel compared to placebo on symptoms of genital herpes’’
Prof. Jean-Paul Ortonne, Head of Clinical Department, Dermatologist, University hospital center l’Archet 2 – F - 06200 Nice
Multi-centre study conducted by a single-blinded investigator on two parallel groups of 20 patients (total: 40 patients); this study is part of the CE marking.
2 phases :
- An eligibility period lasting a maximum of 4 months during which recurrence of genital herpes 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 genital herpes within the 4- month eligibility period. As soon as the patients experience the first symptoms of recurrent genital herpes, they must consult the investigator within 36 hours.
Treatment phase : Visits at D1, D2, D3, D8 and D15
Intensity score of subjective symptoms (burning pain, itching, prickling and their sum) evaluated by the subject on a visual analogue scale (VAS)
- Lesion clinical scores (oedema, erythema, vesicles) on a scale from 0 to 3.
- Time to cure evaluated by the investigator.
Safety: Local tolerance: test product acceptability and tolerance questionnaire.
Evaluation of the activity and safety of CS21 barrier genital gel compared to placebo in symptoms of genital herpes recurrences: a randomized clinical trial.
A . Khémis, Luc Duteil, A.C. Coudert, Y. Tillet, O. Dereure, J.P. Ortonne
JEADV : Journal of the European Academy of Dermatology and Venereology