Trial · NCT02864082
A Safety and Tolerability Study of Topical PAT-001 in Congenital Ichthyosis
NCT02864082, Phase 2, Completed, Patagonia Pharmaceuticals, LLC; results first posted 2021-09-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Tolerability Study of Topical PAT-001 in Congenital Ichthyosis. Trials, record NCT02864082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02864082
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Tolerability Study of Topical PAT-001 in Congenital Ichthyosis
- NCT number
- NCT02864082
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Patagonia Pharmaceuticals, LLC
- Conditions
- Congenital Ichthyosis
- Interventions
- PAT-001, 0.1%, PAT-001, 0.2%, Vehicle for PAT-001 0.1%, Vehicle for PAT-001 0.2%
- First posted
- 2016-08-11
- Last updated
- 2021-09-29
- Results first posted
- 2021-09-02
- Limitations and caveats
- Data should be interpreted with caution due to small sample sizes
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Day 0 through Day 57 (Weeks 0-8) | The number of participants with AEs will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported. |
| Primary | Incidence of Local Skin Reactions (LSRs) in Participants Treated With PAT-001 0.1%, 0.2% and/or Vehicle | Up to Day 84 (Weeks 0-12) | LSRs including burning/stinging, pain, and pruritus (itch) will be assessed in each Treatment Area using a four-point ordinal scale where 0=none, 1=mild, 2=moderate, and 3=severe (based on the investigator's evaluation of the skin reaction) at each clinic visit to allow a comparison between Treatment Groups and Test Articles. Only LSRs that require medical intervention (e.g., prescription medication) or require withholding or reduction in dosing frequency of the test articles will be documented in this LSR Table. Any LSRs that are not listed here will be recorded as AEs. |
| Secondary | Number of Participants Achieving Improvement to State of Clear, Almost Clear or Mild in the Investigator's Global Assessment (IGA) Using a Five-point Scale at Day 57 (Part 1) | Up to Day 57 | Overall severity of ichthyosis will be graded using a five-point scale Investigator Global Assessment (IGA) based upon a 5 point scale going from 0=clear., 1=almost clear, 2=mild, 3=moderate to 4=severe. Scoring is based upon investigator evaluation. This is a static morphological scale that refers to a point in time and not a comparison to Baseline. |
| Secondary | Number of Participants Achieving an Improvement of at Least 1 Point Score in the Individual Clinical Signs/Symptoms of Erythema, Scaling, Fissuring and Papulation/Lichenification Using a Five-point Scale | Up to Day 57 (Weeks 0-8) | Overall severity of erythema (redness), scaling , fissuring (cracks in skin), and papulation/lichenification (skin thickening, increased pigmentation and/or exaggerated skin lines, formation of papules) will be graded using a five-point scale from 0=clear, 1=almost clear, 2=mild, 3=moderate to 4=severe. This is a static morphological scale that refers to a point in time and not a comparison to Baseline. This scoring is based upon investigator discretion. |
| Other | Pharmacokinetics of PAT-001 0.1% and 0.2% at Different Timepoints | Day 1 (0,1, 2, 3, and 4 hours post Dose) | Serum concentrations for PAT-001 0.1% and PAT-001 0.2% looking at blood levels obtained at timepoints outlined |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Day 0 through Day 57 (Weeks 0-8) | Number of Participants with Adverse events | participants | NUMBER |
| PRIMARY | Incidence of Local Skin Reactions (LSRs) in Participants Treated With PAT-001 0.1%, 0.2% and/or Vehicle | Up to Day 84 (Weeks 0-12) | Participants may have had more than one type of LSR | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Improvement to State of Clear, Almost Clear or Mild in the Investigator's Global Assessment (IGA) Using a Five-point Scale at Day 57 (Part 1) | Up to Day 57 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Achieving an Improvement of at Least 1 Point Score in the Individual Clinical Signs/Symptoms of Erythema, Scaling, Fissuring and Papulation/Lichenification Using a Five-point Scale | Up to Day 57 (Weeks 0-8) | IGA score improvement of at least 1 point on IGA for scaling, erythema, papulation/lichenification and fissuring at Day 57 in patients receiving continuous 0.1% and 0.2% PAT-001 | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Pharmacokinetics of PAT-001 0.1% and 0.2% at Different Timepoints | Day 1 (0,1, 2, 3, and 4 hours post Dose) | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 1 PAT-001 0.1% | Number of Subjects with TEAE | 7 | participants | |
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 2 PAT-001 0.2% | Number of Subjects with TEAE | 7 | participants | |
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 1 Vehicle | Number of Subjects with TEAE | 5 | participants | |
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 2 Vehicle | Number of Subjects with TEAE | 5 | participants | |
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 1 PAT-001 0.1% | Number of Treatment Emergent Adverse Events (TEAE) within treatment area | 4 | participants | |
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 2 PAT-001 0.2% | Number of Treatment Emergent Adverse Events (TEAE) within treatment area | 5 | participants | |
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 1 Vehicle | Number of Treatment Emergent Adverse Events (TEAE) within treatment area | 3 | participants | |
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 2 Vehicle | Number of Treatment Emergent Adverse Events (TEAE) within treatment area | 3 | participants | |
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 1 PAT-001 0.1% | Number of Deaths due to TEAE | 0 | participants | |
| Number of Participants With Adverse Events (AEs) in Part 1 of Trial (Weeks 0-8) | Group 2 PAT-001 0.2% | Number of Deaths due to TEAE | 0 | participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 PAT-001 0.1% and Vehicle | 10 | |
| Overall Study | STARTED | Group 2 PAT-001 0.2% and Vehicle | 9 | |
| Overall Study | COMPLETED | Group 1 PAT-001 0.1% and Vehicle | 7 | |
| Overall Study | COMPLETED | Group 2 PAT-001 0.2% and Vehicle | 5 | |
| Overall Study | NOT COMPLETED | Group 1 PAT-001 0.1% and Vehicle | 3 | |
| Overall Study | NOT COMPLETED | Group 2 PAT-001 0.2% and Vehicle | 4 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Application site pruritis | General disorders | Group 1 PAT-001 0.1% | 3 | 10 | 6 |
| other | Application site pruritis | General disorders | Group 2 PAT-001 0.2% | 0 | 9 | 0 |
| other | Application site pruritis | General disorders | Group 1 Vehicle | 2 | 10 | 2 |
| other | Application site pruritis | General disorders | Group 2 Vehicle | 1 | 9 | 1 |
| other | C. difficile colitis | Infections and infestations | Group 1 PAT-001 0.1% | 0 | 10 | 0 |
| other | C. difficile colitis | Infections and infestations | Group 2 PAT-001 0.2% | 1 | 9 | 1 |
| other | C. difficile colitis | Infections and infestations | Group 1 Vehicle | 0 | 10 | 0 |
| other | C. difficile colitis | Infections and infestations | Group 2 Vehicle | 0 | 9 | 0 |
| other | Arthropod bite | Injury, poisoning and procedural complications | Group 1 PAT-001 0.1% | 2 | 10 | 2 |
| other | Arthropod bite | Injury, poisoning and procedural complications | Group 2 PAT-001 0.2% | 0 | 9 | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 PAT-001 0.1% | 0 | 10 |
| Total, all-cause mortality | Group 2 PAT-001 0.2% | 0 | 9 |
| Total, all-cause mortality | Group 1 Vehicle | 0 | 10 |
| Total, all-cause mortality | Group 2 Vehicle | 0 | 9 |
| Total, other adverse events | Group 1 PAT-001 0.1% | 7 | 10 |
| Total, other adverse events | Group 2 PAT-001 0.2% | 7 | 9 |
| Total, other adverse events | Group 1 Vehicle | 2 | 10 |
| Total, other adverse events | Group 2 Vehicle | 1 | 9 |
| Total, serious adverse events | Group 1 PAT-001 0.1% | 0 | 10 |
| Total, serious adverse events | Group 2 PAT-001 0.2% | 1 | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT02864082
GET https://conductscience.org/api/trials/v1/NCT02864082/results?page=2