A Phase 2 interventional study of Topical Minocycline Foam FXFM244 in Impetigo, sponsored by Vyne Therapeutics Inc.. Completed at 1 site in Israel. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2013-12-10.
Sponsored by Vyne Therapeutics Inc. · Phase 2, Interventional, and Treatment
Impetigo is a common, highly infectious skin disease caused by bacterial infection and characterized by crusting skin lesions. It is most common in children, particularly children in unhealthy living conditions. In adults, it may follow other skin disorders. Impetigo is caused primarily by the bacteria Streptococcus pyogenes and/or Staphylococcus aureus, which can also be isolated from impetigo lesions.
This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in impetigo patients.
A randomized, parallel-group, double (Investigator, patient) blind, comparative dose range finding clinical trial.
The study will involve two treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% , in a blinded fashion. Patients will be treated twice daily for 7 days. Following the screening period and baseline visit, study subjects will return at days 3, 7 and 14. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.
26 studies on the registry are indexed under Impetigo; 3 are open to participants now.
This study's enrollment of 32 is below the median of 314 across 22 interventional studies indexed under Impetigo.
Browse Impetigo studies →Vyne Therapeutics Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 13 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Minocycline Foam FXFM244 - 4%
Drug: Topical Minocycline Foam FXFM244
Minocycline Foam FXFM244 - 1%
Drug: Topical Minocycline Foam FXFM244
FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days
Decrease in lesion count
Time frame: 7 days
The severity of the overall impetigo condition will be measured at baseline and at all follow-up visits. The severity will be assessed and graded based on the scales for Investigator's Global Assessment and bacteriological testing.
Time frame: Days 3, 7 and 14
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vyne Therapeutics Inc.