Trial · NCT02249767
Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
NCT02249767, Phase 3, Completed, Spear Pharmaceuticals; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel. Trials, record NCT02249767. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02249767
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
- NCT number
- NCT02249767
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 574 participants, actual
- Lead sponsor
- Spear Pharmaceuticals
- Conditions
- Acne
- Interventions
- Tretinoin
- First posted
- 2014-09-26
- Last updated
- 2020-02-10
- Results first posted
- 2020-01-13
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Baseline Acne Lesions at Week 12 | Baseline and 12 weeks | Percent change in baseline in inflammatory and non-inflammatory lesions at week 12. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Baseline Acne Lesions at Week 12 | Baseline and 12 weeks | This is Per protocol population (PP) Analysis. Generic Tretinoin Intent to Treat (ITT) started 222- 22 excluded as not following protocol= 200 PP. Brand Tretinoin 220 ITT - 11 excluded not following Protocol=209 PP. Placebo 107 ITT - 7 excluded = 100 PP Percent change from baseline in acne lesions | Percent reduction | MEAN |
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 |
|---|---|---|---|---|---|
| Percent Change in Baseline Acne Lesions at Week 12 | Generic Tretinoin | -32.34 | Standard Deviation 30.35 | Percent reduction | |
| Percent Change in Baseline Acne Lesions at Week 12 | Brand Tretinoin | -37.32 | Standard Deviation 28.81 | Percent reduction | |
| Percent Change in Baseline Acne Lesions at Week 12 | Placebo Vehicle | -26.38 | Standard Deviation 32.33 | Percent reduction |
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 | Generic Tretinoin | 230 | |
| Overall Study | STARTED | Brand Tretinoin | 229 | |
| Overall Study | STARTED | Placebo Vehicle | 115 | |
| Overall Study | COMPLETED | Generic Tretinoin | 222 | |
| Overall Study | COMPLETED | Brand Tretinoin | 220 | |
| Overall Study | COMPLETED | Placebo Vehicle | 107 | |
| Overall Study | NOT COMPLETED | Generic Tretinoin | 8 | |
| Overall Study | NOT COMPLETED | Brand Tretinoin | 9 | |
| Overall Study | NOT COMPLETED | Placebo Vehicle | 8 |
Source ClinicalTrials.gov
Adverse events3
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 from Drug | Skin and subcutaneous tissue disorders | Generic Tretinoin | 49 | 230 | |
| other | Irritation from Drug | Skin and subcutaneous tissue disorders | Brand Tretinoin | 46 | 229 | |
| other | Irritation from Drug | Skin and subcutaneous tissue disorders | Placebo Vehicle | 26 | 115 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Generic Tretinoin | 0 | 230 |
| Total, all-cause mortality | Brand Tretinoin | 0 | 229 |
| Total, all-cause mortality | Placebo Vehicle | 0 | 115 |
| Total, other adverse events | Generic Tretinoin | 49 | 230 |
| Total, other adverse events | Brand Tretinoin | 46 | 229 |
| Total, other adverse events | Placebo Vehicle | 26 | 115 |
| Total, serious adverse events | Generic Tretinoin | 0 | 230 |
| Total, serious adverse events | Brand Tretinoin | 0 | 229 |
| Total, serious adverse events | Placebo Vehicle | 0 | 115 |
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/NCT02249767
GET https://conductscience.org/api/trials/v1/NCT02249767/registered