Trial · NCT00961896
A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients
NCT00961896, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients. Trials, record NCT00961896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00961896
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients
- NCT number
- NCT00961896
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients
- Interventions
- Vehicle, LDE225 0.25%, LDE225 0.75%
- First posted
- 2009-08-19
- Last updated
- 2015-11-03
- Other registries' IDs
- eudract:2008-005506-40
- Results first posted
- 2015-09-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of BCCs With Complete and at Least Partial Clinical Clearance | 4 weeks, 6 weeks, 9 weeks | Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline). |
| Primary | Number of Participants With at Least Partial Clinical Clearance (Part I) | day 8, day 15, day 22, day 29 | Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline). |
| Secondary | Change From Baseline in Tumor Measurements (Part I) | 4 weeks | Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the "3D LIFEVIZ Micro system", which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Tumor Measurements (Part II) | 4 weeks, 6 weeks, 9 weeks | Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated.. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the "3D LIFEVIZ Micro system", which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Tumor Measurements (by Tumor) (Part I) | 4 weeks | Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the "3D LIFEVIZ Micro system", which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Tumor Measurements (by Tumor) (Part II) | 4 weeks, 6 weeks, 9 weeks | Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the "3D LIFEVIZ Micro system", which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of BCCs With Complete and at Least Partial Clinical Clearance | 4 weeks, 6 weeks, 9 weeks | All participants were analyzed. | Percentage of BCCs | NUMBER |
| SECONDARY | Change From Baseline in Tumor Measurements (Part I) | 4 weeks | All part I participants were included in the analysis. | Percent change in tumor measurement | MEAN |
| SECONDARY | Change From Baseline in Tumor Measurements (Part II) | 4 weeks, 6 weeks, 9 weeks | Part II participants with evaluable data (n=3,6) were included in the analysis. | percent change in tumor measurement | MEAN |
| SECONDARY | Change From Baseline in Tumor Measurements (by Tumor) (Part I) | 4 weeks | All part I participants were included in this analysis. | Percent change in tumor measurement | MEAN |
| SECONDARY | Change From Baseline in Tumor Measurements (by Tumor) (Part II) | 4 weeks, 6 weeks, 9 weeks | Part II participants with evaluable data (n=3,6) were included in the analysis. | Percent change in tumor measurement | MEAN |
| PRIMARY | Number of Participants With at Least Partial Clinical Clearance (Part I) | day 8, day 15, day 22, day 29 | All part I participants were included in the analysis. | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | LDE225 (Applied in Parallel With Vehicle) [Part I] | Week 4, at least partial | 92 | Percentage of BCCs | |
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | Vehicle Cream (Applied in Parallel With LDE225 [Part I] | Week 4, at least partial | 7 | Percentage of BCCs | |
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | LDE225 0.25% [Part II] | Week 4, at least partial | 83 | Percentage of BCCs | |
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | LDE225 0.75% [Part II] | Week 4, at least partial | 77 | Percentage of BCCs | |
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | LDE225 (Applied in Parallel With Vehicle) [Part I] | Week 4, complete | 23 | Percentage of BCCs | |
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | Vehicle Cream (Applied in Parallel With LDE225 [Part I] | Week 4, complete | 0 | Percentage of BCCs | |
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | LDE225 0.25% [Part II] | Week 4, complete | 0 | Percentage of BCCs | |
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | LDE225 0.75% [Part II] | Week 4, complete | 0 | Percentage of BCCs | |
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | LDE225 (Applied in Parallel With Vehicle) [Part I] | Week 6, at least partial | NA | Percentage of BCCs | |
| Percentage of BCCs With Complete and at Least Partial Clinical Clearance | Vehicle Cream (Applied in Parallel With LDE225 [Part I] | Week 6, at least partial | NA | Percentage of BCCs |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Part I Participants | 8 | |
| Overall Study | STARTED | LDE225 0.25% [Part II] | 3 | |
| Overall Study | STARTED | LDE225 0.75% [Part II] | 7 | |
| Overall Study | COMPLETED | All Part I Participants | 8 | |
| Overall Study | COMPLETED | LDE225 0.25% [Part II] | 3 | |
| Overall Study | COMPLETED | LDE225 0.75% [Part II] | 6 | |
| Overall Study | NOT COMPLETED | All Part I Participants | 0 | |
| Overall Study | NOT COMPLETED | LDE225 0.25% [Part II] | 0 | |
| Overall Study | NOT COMPLETED | LDE225 0.75% [Part II] | 1 |
Source ClinicalTrials.gov
Adverse events69
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 | EXTERNAL EAR INFLAMMATION | Ear and labyrinth disorders | All Part I Participants | 0 | 8 | |
| other | EXTERNAL EAR INFLAMMATION | Ear and labyrinth disorders | 0.25% LDE225 [Part II] | 0 | 3 | |
| other | EXTERNAL EAR INFLAMMATION | Ear and labyrinth disorders | 0.75% LDE225 [Part II] | 1 | 7 | |
| other | CONJUNCTIVITIS | Eye disorders | All Part I Participants | 0 | 8 | |
| other | CONJUNCTIVITIS | Eye disorders | 0.25% LDE225 [Part II] | 0 | 3 | |
| other | CONJUNCTIVITIS | Eye disorders | 0.75% LDE225 [Part II] | 1 | 7 | |
| other | FATIGUE | General disorders | All Part I Participants | 0 | 8 | |
| other | FATIGUE | General disorders | 0.25% LDE225 [Part II] | 0 | 3 | |
| other | FATIGUE | General disorders | 0.75% LDE225 [Part II] | 1 | 7 | |
| other | INFECTION | Infections and infestations | All Part I Participants | 0 | 8 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Part I Participants | ||
| Total, all-cause mortality | 0.25% LDE225 [Part II] | ||
| Total, all-cause mortality | 0.75% LDE225 [Part II] | ||
| Total, other adverse events | All Part I Participants | 7 | 8 |
| Total, other adverse events | 0.25% LDE225 [Part II] | 2 | 3 |
| Total, other adverse events | 0.75% LDE225 [Part II] | 5 | 7 |
| Total, serious adverse events | All Part I Participants | 0 | 8 |
| Total, serious adverse events | 0.25% LDE225 [Part II] | 0 | 3 |
| Total, serious adverse events | 0.75% LDE225 [Part II] | 1 | 7 |
Source ClinicalTrials.gov
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.
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