Effect of CD07805/47 Gel in Subjects Presenting With Flushing Related to Erythematotelangiectatic or Papulopustular Rosacea
CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo
+ Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo
+ CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47
Rosácea
+ Enfermedades de la Piel
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 2014
Fecha en la que se inscribió al primer participante.The objectives of this study in rosacea patients (type I\&II) are: * to demonstrate objectively that CD07805/47 0.5% gel is able to prevent a flush induced by a specific trigger (hot water) in controlled condition; * to demonstrate that CD07805/47 0.5% gel is able to prevent a flush whatever the trigger in everyday life condition; * to investigate if reduction in redness is associated with a decrease in skin sensations such as heat, stinging/burning, skin tension and sweating; * to demonstrate that such efficacy on transient redness and sensations takes place in both populations (rosacea type I and rosacea type II). This is a single-centre, randomized, Investigator masked, placebo controlled study comprising the following periods: A screening period of maximum 4 weeks A one-week treatment phase (Period 1) with 3 sessions using the flush model, every other day. This Period 1 includes a cross-over design (first and third sessions) and a split face design (second session). During this period, thirty six (36) subjects will receive on site the study drugs as follows (the order of each session being randomized): * CD07805/47 placebo gel on both sides of the face, * one side of the face treated with CD07805/47 0.5% gel, the other side treated with the CD07805/47 placebo gel (the allocation of treatment on each half-face will be determined according to a randomization list), * CD07805/47 0.5% gel on both sides of the face; A 2-days wash-out period (between Period 1 and Period 2) with no treatment on either side of the face A 4-week treatment phase (Period 2) corresponding to a cross-over design during which the subjects will apply themselves the study drugs at home on the whole face, once daily 7 days per week. The subjects will be divided in 2 groups of eighteen (18) subjects and will receive either the CD07805/47 0.5% gel the first 2 weeks and then the CD07805/47 placebo gel or the CD07805/47 placebo gel the first 2 weeks and then the CD07805/47 0.5% gel, according to randomization. All the subjects taking part into the study will not be randomized separately in the two periods but to the full sequence at the beginning of the clinical trial (same randomization number during all the study), explaining the arms/groups detailed in the section "Arms and Interventions". Only primary efficacy endpoint: total number of flushes for each 2-week period will be detailed in the outcome measures section. The other endpoints are secondary or exploratory. The purpose of Period 1 is to assess whether simpler and shorter designs based on flush induced by a trigger could be as efficient to detect prevention of flush than the more classical and longer design of Period 2.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 34 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.4 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
ExperimentalGrupo IV
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación