Trial · NCT00489086
Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
NCT00489086, Phase 2, Completed, UCSF Benioff Children's Hospital Oakland; results first posted 2016-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face. Trials, record NCT00489086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00489086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
- NCT number
- NCT00489086
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Conditions
- Neoplastic Syndrome
- Interventions
- tazarotene
- First posted
- 2007-06-21
- Last updated
- 2020-10-29
- Results first posted
- 2016-02-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate | 36 months | The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient's "target" lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less. |
| Secondary | Time to Lesion Clearance | 36 months | |
| Secondary | Time to Progression | 36 months | |
| Secondary | Estimated Duration of Complete Response | 36 months | |
| Secondary | Overall Response at Treated Lesions | 36 months |
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 | Complete Response Rate | 36 months | N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Lesion Clearance | 36 months | N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Progression | 36 months | N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Estimated Duration of Complete Response | 36 months | N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response at Treated Lesions | 36 months | N=2 participants excluded from analysis: N=1 due to revised BCNS diagnosis and N=1 because unable to confirm administration of at least one dose of tazarotene. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate | Tazarotene Cream | 2 | Participants | ||
| Time to Lesion Clearance | Tazarotene Cream | NA | Participants | ||
| Time to Progression | Tazarotene Cream | NA | Participants | ||
| Estimated Duration of Complete Response | Tazarotene Cream | NA | Participants | ||
| Overall Response at Treated Lesions | Tazarotene Cream | NA | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tazarotene Cream | 36 | |
| Overall Study | Completed 18 Months | Tazarotene Cream | 23 | |
| Overall Study | COMPLETED | Tazarotene Cream | 13 | |
| Overall Study | NOT COMPLETED | Tazarotene Cream | 23 |
Source ClinicalTrials.gov
Adverse events10
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 | irritation | Skin and subcutaneous tissue disorders | Tazarotene Cream | 6 | 36 | |
| other | dryness | Skin and subcutaneous tissue disorders | Tazarotene Cream | 6 | 36 | |
| other | inflammation | Skin and subcutaneous tissue disorders | Tazarotene Cream | 1 | 36 | |
| other | itching | Skin and subcutaneous tissue disorders | Tazarotene Cream | 3 | 36 | |
| other | peeling | Skin and subcutaneous tissue disorders | Tazarotene Cream | 4 | 36 | |
| other | edema | Skin and subcutaneous tissue disorders | Tazarotene Cream | 1 | 36 | |
| other | rash | Skin and subcutaneous tissue disorders | Tazarotene Cream | 4 | 36 | |
| other | erythema | Skin and subcutaneous tissue disorders | Tazarotene Cream | 6 | 36 | |
| serious | prostate cancer diagnosis | Renal and urinary disorders | Tazarotene Cream | 1 | 36 | |
| serious | cellulitis and maxillary sinusitis | Ear and labyrinth disorders | Tazarotene Cream | 1 | 36 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tazarotene Cream | 0 | 36 |
| Total, other adverse events | Tazarotene Cream | 31 | 36 |
| Total, serious adverse events | Tazarotene Cream | 2 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24441673 | RESULT |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA082103 | Cancer Center Support Grant | ASHWORTH, ALAN | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL CANCER INSTITUTE | 1999 to 2025 | NIH RePORTER |
| R01CA109584 | Chemoprevention of Basal Cell Carcinomas with Tazarotene | EPSTEIN, ERVIN HAROLD | CHILDREN'S HOSPITAL & RES CTR AT OAKLAND | NATIONAL CANCER INSTITUTE | 2004 to 2009 | NIH RePORTER |
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/NCT00489086
GET https://conductscience.org/api/trials/v1/NCT00489086/registered