Trial · NCT01243450
Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
NCT01243450, Phase 3, Completed, Spear Pharmaceuticals; results first posted 2014-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo. Trials, record NCT01243450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01243450
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
- NCT number
- NCT01243450
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 958 participants, actual
- Lead sponsor
- Spear Pharmaceuticals
- Conditions
- Acne
- Interventions
- Tretinoin, placebo
- First posted
- 2010-11-18
- Last updated
- 2020-01-03
- Results first posted
- 2014-11-18
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acne Lesion Percent Reduction | 12 week | Reduction in number of Acne lesions by counting over 12 weeks |
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 | Acne Lesion Percent Reduction | 12 week | percent reduction of number of lesions | 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 |
|---|---|---|---|---|---|
| Acne Lesion Percent Reduction | Active Generic | -54.3 | Standard Deviation 10 | percent reduction of number of lesions | |
| Acne Lesion Percent Reduction | Placebo | -35 | Standard Deviation 8 | percent reduction of number of lesions | |
| Acne Lesion Percent Reduction | Brand | -53.5 | Standard Deviation 10 | percent reduction of number of lesions |
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 | Active Generic | 401 | |
| Overall Study | STARTED | Placebo | 135 | |
| Overall Study | STARTED | Brand | 404 | |
| Overall Study | COMPLETED | Active Generic | 318 | |
| Overall Study | COMPLETED | Placebo | 110 | |
| Overall Study | COMPLETED | Brand | 337 | |
| Overall Study | NOT COMPLETED | Active Generic | 83 | |
| Overall Study | NOT COMPLETED | Placebo | 25 | |
| Overall Study | NOT COMPLETED | Brand | 67 |
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 |
|---|---|---|---|---|---|---|
| serious | Appendicitis | Gastrointestinal disorders | Active Generic | 1 | 401 | 1 |
| serious | Appendicitis | Gastrointestinal disorders | Placebo | 0 | 135 | 0 |
| serious | Appendicitis | Gastrointestinal disorders | Brand | 1 | 404 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Generic | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Brand | ||
| Total, other adverse events | Active Generic | 0 | 401 |
| Total, other adverse events | Placebo | 0 | 135 |
| Total, other adverse events | Brand | 0 | 404 |
| Total, serious adverse events | Active Generic | 1 | 401 |
| Total, serious adverse events | Placebo | 0 | 135 |
| Total, serious adverse events | Brand | 1 | 404 |
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/NCT01243450
GET https://conductscience.org/api/trials/v1/NCT01243450/registered