Rosacea
Conditions
Keywords
rosacea, clindamycin, tretinoin, clinical study, treatment
Brief summary
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.
Detailed description
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.
Interventions
Applied on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
DRUGPlacebo gel
Applied placebo gel with no active medication to entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
Sponsors
Medicis Pharmaceutical Corporation
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects 18 years of age and older. 2. Clinical diagnosis of papulopustular facial rosacea. 3. A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules). 4. Willing and able to understand and sign informed consent. 5. Able to complete study and comply with study procedures.
Exclusion criteria
1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment. 2. History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis, bloody diarrhea) or similar symptoms. 3. Use of topical rosacea treatments in the past 2 weeks. 4. Use of systemic antibiotics in the past 4 weeks. 5. Use of systemic retinoids within the past 3 months. 6. Use of laser or light based rosacea treatments within the past 2 months. 7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments. 8. Current drug or alcohol abuse. 9. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or acne vulgaris. 10. Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study. 11. Subjects who are pregnant or planning a pregnancy. 12. Use of any investigational therapy within the past 4 weeks. 13. Known hypersensitivity or previous allergic reaction to clindamycin or retinoids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at MGH and Stanford University Hospital.
Pre-assignment details
Some subjects required a wash-out of medications they were using. Subjects were excluded if they did not have enough lesions.
Participants by arm
| Arm | Count |
|---|---|
| Clindamycin/Tretinoin Gel Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks | 43 |
| Placebo Gel Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks | 40 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo Gel | Clindamycin/Tretinoin Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 42 Participants | 81 Participants |
| Age Continuous | 51.2 years STANDARD_DEVIATION 14 | 53.2 years STANDARD_DEVIATION 13.6 | 52.17 years STANDARD_DEVIATION 13.74 |
| Region of Enrollment United States | 40 participants | 43 participants | 83 participants |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 59 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 41 | 11 / 39 |
| serious Total, serious adverse events | 0 / 43 | 0 / 40 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindamycin/Tretinoin Gel | Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | .83 lesions | Standard Deviation 10.84 |
| Placebo | Mean Change in Number of Inflammatory Lesions From Baseline to Week 12 | -3.13 lesions | Standard Deviation 13.28 |
p-value: 0.15t-test, 2 sided