Trial · NCT03285477
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions | Day 57 | ITT population included all participants randomized in the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57 | Day 57 | ITT population included all participants randomized in the study. | percentage of participants | NUMBER |
| SECONDARY | Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57 | Days 8, 15, 29 and 57 | ITT population included all participants randomized in the study. | lesion count | MEDIAN |
| SECONDARY | Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57 | 3, 6, 9 and 12 months post-Day 57 | Recurrence Follow-up Population includes participants achieved complete clearance at the Day 57visit. The recurrence rate was evaluated only for KX2-391 Ointment 1% arm, pre-specified in protocol. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR) | Day 57 | Safety analysis population consisted of all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Pigmentation and Scarring in the Treatment Area | Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57 | Safety analysis population consisted of all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests | Baseline (Day 1 predose) up to Day 57 | Safety analysis population included all randomized participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57 | From Day 57 up to 12-months post-Day 57 | Recurrence Follow-up Population includes participants achieved complete clearance at the Day 57 visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis | From Baseline (Day 1 predose) up to Day 57 | Safety Population included all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Safety Observations- Vital Signs | From Baseline (Day 1 predose) up to Day 57 | Safety analysis population consisted of all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Safety Observations- Physical Examination | From Baseline (Day 1 predose) up to Day 57 | Safety analysis population included all randomized participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs) | From Baseline (Day 1 predose) up to Day 57 | Safety analysis population consisted of all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03285477/outcomes