Trial · NCT02952898
Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
NCT02952898, Phase 3, Completed, Balmoral Medical company; results first posted 2019-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses. Trials, record NCT02952898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02952898
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
- NCT number
- NCT02952898
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 665 participants, actual
- Lead sponsor
- Balmoral Medical company
- Conditions
- Actinic Keratosis
- Interventions
- GDC 695, Diclofenac Sodium Gel, 3%, Vehicle gel
- First posted
- 2016-11-02
- Last updated
- 2020-01-07
- Results first posted
- 2019-01-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Complete Clearance of AK Lesions | Day 90 (30 days after completion of 60 days of treatment) | Complete Clearance was defined as 100% clearance of all Actinic Keratosis (AK) lesions (having a count of zero AKs) in the treatment area (face or bald scalp) at the Day 90 visit (30 Days Post Treatment). |
| Other | Adverse Events (AEs) | Day 0 through Day 90 | AEs will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Complete Clearance of AK Lesions | Day 90 (30 days after completion of 60 days of treatment) | Analysis shown is based on the modified Intent-to-Treat (mITT) population, defined as all randomized subjects who met the following requirements, 1) met all inclusion/exclusion criteria; 2) applied at least one dose of test article; 3) and returned for at least one post-baseline evaluation clinic visit (Visits 3, 5, or 6). | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Adverse Events (AEs) | Day 0 through Day 90 |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Complete Clearance of AK Lesions | GDC 695 Gel | 30.2 | percentage of participants | ||
| Number of Subjects With Complete Clearance of AK Lesions | Diclofenac Sodium Gel | 25.7 | percentage of participants | ||
| Number of Subjects With Complete Clearance of AK Lesions | Placebo | 9.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GDC 695 Gel | 220 | |
| Overall Study | STARTED | Diclofenac Sodium Gel | 221 | |
| Overall Study | STARTED | Placebo | 224 | |
| Overall Study | COMPLETED | GDC 695 Gel | 198 | |
| Overall Study | COMPLETED | Diclofenac Sodium Gel | 202 | |
| Overall Study | COMPLETED | Placebo | 209 | |
| Overall Study | NOT COMPLETED | GDC 695 Gel | 22 | |
| Overall Study | NOT COMPLETED | Diclofenac Sodium Gel | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 15 |
Source ClinicalTrials.gov
Adverse events51
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 erythema | General disorders | GDC 695 | 4 | 218 | 4 |
| other | Application site erythema | General disorders | Diclofenac Sodium Gel | 3 | 220 | 3 |
| other | Application site erythema | General disorders | Placebo | 1 | 223 | 1 |
| other | Application site oedema | General disorders | GDC 695 | 3 | 218 | 3 |
| other | Application site oedema | General disorders | Diclofenac Sodium Gel | 2 | 220 | 2 |
| other | Application site oedema | General disorders | Placebo | 0 | 223 | 0 |
| other | Application site pain | General disorders | GDC 695 | 3 | 218 | 3 |
| other | Application site pain | General disorders | Diclofenac Sodium Gel | 1 | 220 | 1 |
| other | Application site pain | General disorders | Placebo | 1 | 223 | 1 |
| other | Application site pruritus | General disorders | GDC 695 | 3 | 218 | 3 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GDC 695 | 0 | 218 |
| Total, all-cause mortality | Diclofenac Sodium Gel | 0 | 220 |
| Total, all-cause mortality | Placebo | 0 | 223 |
| Total, other adverse events | GDC 695 | 19 | 218 |
| Total, other adverse events | Diclofenac Sodium Gel | 14 | 220 |
| Total, other adverse events | Placebo | 6 | 223 |
| Total, serious adverse events | GDC 695 | 1 | 218 |
| Total, serious adverse events | Diclofenac Sodium Gel | 3 | 220 |
| Total, serious adverse events | Placebo | 5 | 223 |
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.
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/NCT02952898
GET https://conductscience.org/api/trials/v1/NCT02952898/events?page=2