Dettagli per singolo studio

DEC-NET Serial number GB265

Published online	30/06/2004 12.29.00
Last updated	08/08/2005 13.18.40

Other protocol ID number	N0220088543
This trial has been approved by an ethics committee
Current trial status	Terminated (withdrawn)
First subject enrolment Target N. of subjects	09/2001 N/A
Major Disease (ICD9 class)	ACNE NEC
Experimental drug
Isotretinoin Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	2 - 16 years
Eligibility criteria
Inclusion criteria
All children in whom the decision to treat with Isotretinoin has been made on clinical grounds by the consultant dermatologist will be approached for inclusion into the study.
Exclusion criteria
Informed consent not given for participation into trial
Trial design/methodology
Phase	4
Kind of study	Safety
Design	Controlled 0 Observational
Purpose of study
To determine whether Isotretinoin causes predictable fusion of the epiphyses in pubertal patients treated for acne.
Primary outcomes
1. Leg length measurement 2. Bone age mesurement 3. Epiphysis at wrist measurement


Summary of study design, objectives, and ongoing research findings
(Withdrawn due to too few recruitments) After informed consent has been obtained, the subjects will be measured (height and knemometry - lower leg length) and a wrist x-ray performed to estimate epiphyseal maturation. The subjects will be asked to delay starting their treatment for 4 weeks, during which time they will be measured weekly, them, after starting treatment, they will be measured alternate weekly for the 16 weeks course of Isotretinoin with a bone age taken at the end of the course.