Trial · NCT00823901
Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea
NCT00823901, Phase 2, Phase 3, Completed, Massachusetts General Hospital; results first posted 2012-06-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea. Trials, record NCT00823901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00823901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea
- NCT number
- NCT00823901
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 83 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Rosacea
- Interventions
- Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel, Placebo gel
- First posted
- 2009-01-16
- Last updated
- 2012-06-25
- Results first posted
- 2012-06-15
- Limitations and caveats
- This study is limited by relatively small number of subjects. In addition, overall assessment of acne rosacea severity as determined by subjects' self-assessment was not performed.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | Baseline, week 12 | The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values. |
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 | Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | Baseline, week 12 | Intent to treat (ITT) population. Participants who were randomized but only had baseline visit (never began treatment) were excluded from the analysis. Last observation carried forward (LOCF) was also used. | lesions | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | Clindamycin/Tretinoin Gel | .83 | Standard Deviation 10.84 | lesions | |
| Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | Placebo | -3.13 | Standard Deviation 13.28 | lesions |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clindamycin/Tretinoin Gel | 43 | |
| Overall Study | STARTED | Placebo Gel | 40 | |
| Overall Study | COMPLETED | Clindamycin/Tretinoin Gel | 39 | |
| Overall Study | COMPLETED | Placebo Gel | 38 | |
| Overall Study | NOT COMPLETED | Clindamycin/Tretinoin Gel | 4 | |
| Overall Study | NOT COMPLETED | Placebo Gel | 2 |
Source ClinicalTrials.gov
Adverse events14
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 | Worsening rosacea | Skin and subcutaneous tissue disorders | Clindamycin/Tretinoin Gel | 7 | 41 | 7 |
| other | Worsening rosacea | Skin and subcutaneous tissue disorders | Placebo Gel | 4 | 39 | 4 |
| other | Facial scaling | Skin and subcutaneous tissue disorders | Clindamycin/Tretinoin Gel | 6 | 41 | 6 |
| other | Facial scaling | Skin and subcutaneous tissue disorders | Placebo Gel | 0 | 39 | 0 |
| other | Facial Dryness | Skin and subcutaneous tissue disorders | Clindamycin/Tretinoin Gel | 5 | 41 | 5 |
| other | Facial Dryness | Skin and subcutaneous tissue disorders | Placebo Gel | 2 | 39 | 2 |
| other | Facial redness | Skin and subcutaneous tissue disorders | Clindamycin/Tretinoin Gel | 4 | 41 | 4 |
| other | Facial redness | Skin and subcutaneous tissue disorders | Placebo Gel | 2 | 39 | 2 |
| other | Facial burning sensation | Skin and subcutaneous tissue disorders | Clindamycin/Tretinoin Gel | 2 | 41 | 2 |
| other | Facial burning sensation | Skin and subcutaneous tissue disorders | Placebo Gel | 0 | 39 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clindamycin/Tretinoin Gel | ||
| Total, all-cause mortality | Placebo Gel | ||
| Total, other adverse events | Clindamycin/Tretinoin Gel | 29 | 41 |
| Total, other adverse events | Placebo Gel | 11 | 39 |
| Total, serious adverse events | Clindamycin/Tretinoin Gel | 0 | 43 |
| Total, serious adverse events | Placebo Gel | 0 | 40 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Clindamycin/Tretinoin Gel vs Placebo Gel: serious adverse events |
Source Trial comparisons
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/NCT00823901
GET https://conductscience.org/api/trials/v1/NCT00823901/registered