Trial · NCT01135069
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
NCT01135069, Phase 3, Completed, Spear Pharmaceuticals; results first posted 2014-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo. Trials, record NCT01135069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01135069
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
- NCT number
- NCT01135069
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 480 participants, actual
- Lead sponsor
- Spear Pharmaceuticals
- Conditions
- Acne
- Interventions
- Tretinoin microsphere 0.1%, Brand Retin-A Micro tretinoin microsphere gel 0.1%, placebo microsphere gel
- First posted
- 2010-06-02
- Last updated
- 2014-10-27
- Results first posted
- 2014-10-16
- Limitations and caveats
- No unexpected problems.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in Acne | 12 weeks | Counting of acne lesions both inflammatory and non-inflammatory |
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 | Improvement in Acne | 12 weeks | Percent change | 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 |
|---|---|---|---|---|---|
| Improvement in Acne | Generic | -74 | Standard Deviation .05 | Percent change | |
| Improvement in Acne | Brand | -76 | Standard Deviation .04 | Percent change | |
| Improvement in Acne | Placebo | -58 | Standard Deviation .03 | Percent change |
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 | 205 | |
| Overall Study | STARTED | Brand | 209 | |
| Overall Study | STARTED | Placebo | 66 | |
| Overall Study | COMPLETED | Generic | 169 | |
| Overall Study | COMPLETED | Brand | 177 | |
| Overall Study | COMPLETED | Placebo | 56 | |
| Overall Study | NOT COMPLETED | Generic | 36 | |
| Overall Study | NOT COMPLETED | Brand | 32 | |
| Overall Study | NOT COMPLETED | Placebo | 10 |
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 | Skin and subcutaneous tissue disorders | Generic | 26 | 205 | 26 |
| other | Irritation | Skin and subcutaneous tissue disorders | Brand | 29 | 209 | 29 |
| other | Irritation | Skin and subcutaneous tissue disorders | Placebo | 10 | 66 | 10 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Generic | ||
| Total, all-cause mortality | Brand | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Generic | 26 | 205 |
| Total, other adverse events | Brand | 29 | 209 |
| Total, other adverse events | Placebo | 10 | 66 |
| Total, serious adverse events | Generic | 0 | 205 |
| Total, serious adverse events | Brand | 0 | 209 |
| Total, serious adverse events | Placebo | 0 | 66 |
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/NCT01135069
GET https://conductscience.org/api/trials/v1/NCT01135069/registered