Efficacy of Injectable Gentamicin in Hereditary Ichthyosis
ConditionIchthyosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Toulouse
About this trial
This study will evaluate the efficacy and safety of intravenous gentamicin in congenital ichthyosis due to a non-sens mutation. The primary objective is the severity of scales and erythema at the third month, compared to baseline. Secondary objectives will include: the importance of itching, trans epidermal water loss, cutaneous expression of the targeted protein, the security of the drug and patients' satisfaction.
Eligibility criteria
Qualifiers
Adult patients affiliated to a social insurance protection regimen.
Hereditary ichthyosis caused by a homozygous non-sense mutation of a gene responsible for hereditary ichthyosis (TGM1, PNPLA1, ALOX12B, NIPAL4, ALOXE3, SDR9C7, ABCA12, CERS3, SPINK5 and CDSN)
Moderate to severe forms of ichthyosis defined as Validating an Ichthyosis Severity Index score at 2-3 on at least 2 out of 4 areas evaluated (back, upper limbs, lower limbs, back of the foot)
Free, informed consent, written and signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Disqualifiers
Cutaneous signs suggesting a surinfection
Hypersensibility of active substance or one of the gentamicin excipients
Administration of an aminoside in the previous 3 months
Treatment with nephrotoxic or ototoxic medication in the previous 6 weeks
Trial design
Treatments tested in this trial
- Gentamicin Injectable Solution
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov