A Phase 2/3 interventional study of Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel and Placebo gel in Rosacea, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-25.
Sponsored by Massachusetts General Hospital · Phase 2/3, Interventional, and Treatment
The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.
Currently, there is no known cure for rosacea. The most effective treatment is systemic antibiotics, particularly of the tetracycline family. Topical treatments include metronidazole, antibacterials such as erythromycin and clindamycin, sulfacetamide and benzoyl peroxide. Isotretinoin (Accutane) is also used.
225 studies on the registry are indexed under Rosacea; 19 are open to participants now.
This study's enrollment of 83 is above the median of 61 across 195 interventional studies indexed under Rosacea.
Browse Rosacea studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, chin, cheeks) once daily at night for 12 weeks
Drug: Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel
Participants applied Placebo gel with no active medication on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks.
Drug: Placebo gel
Applied on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
Also known as: Ziana
Applied placebo gel with no active medication to entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
Also known as: placebo
Mean Change in Number of Inflammatory Lesions From Baseline to 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.
Time frame: Baseline, week 12
Subjects were recruited at MGH and Stanford University Hospital.
| Milestone | Clindamycin/Tretinoin Gel | Placebo Gel |
|---|---|---|
| Started | 43 | 40 |
| Completed | 39 | 38 |
| Not completed | 4 | 2 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 |
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.
| lesions | Clindamycin/Tretinoin Gel | Placebo |
|---|---|---|
| Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | .83 ± 10.84 | -3.13 ± 13.28 |
Collected over 12 weeks (duration of study participation). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clindamycin/Tretinoin Gel | — | 0/43 (0%) | 29/41 (70.7%) |
| Placebo Gel | — | 0/40 (0%) | 11/39 (28.2%) |
| Event | Clindamycin/Tretinoin Gel | Placebo Gel |
|---|---|---|
| Worsening rosaceaSkin and subcutaneous tissue disorders | 7/41 | 4/39 |
| Facial scalingSkin and subcutaneous tissue disorders | 6/41 | 0/39 |
| Facial DrynessSkin and subcutaneous tissue disorders | 5/41 | 2/39 |
| Facial rednessSkin and subcutaneous tissue disorders | 4/41 | 2/39 |
| Facial itchingSkin and subcutaneous tissue disorders | 3/41 | 2/39 |
| Facial burning sensationSkin and subcutaneous tissue disorders | 2/41 | 0/39 |
| Facial irritationSkin and subcutaneous tissue disorders | 2/41 | 1/39 |
| Age, Categorical(Participants) | Clindamycin/Tretinoin Gel | Placebo Gel | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 42 | 39 | 81 |
| >=65 years | 1 | 1 | 2 |
| Age Continuous(years) | Clindamycin/Tretinoin Gel | Placebo Gel | Total |
|---|---|---|---|
| Mean | 53.2 ± 13.6 | 51.2 ± 14.0 | 52.17 ± 13.74 |
| Sex: Female, Male(Participants) | Clindamycin/Tretinoin Gel | Placebo Gel | Total |
|---|---|---|---|
| Female | 28 | 31 | 59 |
| Male | 15 | 9 | 24 |
| Region of Enrollment(participants) | Clindamycin/Tretinoin Gel | Placebo Gel | Total |
|---|---|---|---|
| United States | 43 | 40 | 83 |
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital