Trial · NCT01803035
A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo
NCT01803035, Phase 2, Completed, Lytix Biopharma AS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo. Trials, record NCT01803035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01803035
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo
- NCT number
- NCT01803035
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 210 participants, estimated
- Lead sponsor
- Lytix Biopharma AS
- Conditions
- Non-bullous Impetigo
- Interventions
- LTX-109 1 %, LTX-109 2 %, Placebo gel
- First posted
- 2013-03-04
- Last updated
- 2014-04-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of LTX-109. | One year | Efficacy of two doses 1% and 2% LTX-109 versus placebo will be measured by clinical response. Clinical response is defined as "Clinical success", "Clinical improvement" and "Clinical failure". Evaluation of the target lesion will be done at day 4, day 6 and day 12 and will be derived from Skin Infection Rating Scale (SIRS). |
| Secondary | Safety of topical administration in treatment of impetigo. | One year | Safety will be monitored through physical examination, compliance with assigned treatment, and recording of adverse events occurring during the study period. Changes in clinical signs and symptoms will be recorded in the SIRS score. An assessment will be done of the target lesion and one overall assessment of the subject non-target lesions. A targeted physical examination will be done if any abnormalities occur. For the study analysis the number of patients with adverse events and the nature of the adverse events will be listed per treatment group. |
| Secondary | Microbiological response of two doses of LTX-109 (1% and 2%) versus placebo in the treatment of impetigo. | One year | Microbiological response will be measured by "Bacteriological Success" or "Bacteriological failure". The response will be derived from bacterial swab cultures, and presence or non-presence of the causative pathogen at each of the follow up visits, day 4, day 6, and day 12. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01803035
GET https://conductscience.org/api/trials/v1/NCT01803035/registered