DOSAGE AND ADMINISTRATION
CUTIVATE Cream may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of (numbers are realigned in columns below) CUTIVATE Cream in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS: Pediatric Use). The safety and efficacy of CUTIVATE Cream in pediatric patients below 3 months of age have not been established. Atopic Dermatitis: Apply a thin film of CUTIVATE Cream to the affected skin areas once or twice daily. Rub in gently. Other Corticosteroid-Responsive Dermatoses: Apply a thin film of CUTIVATE Cream to the affected skin areas twice daily. Rub in gently.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
CUTIVATE Cream should not be used with occlusive dressings. CUTIVATE Cream should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings. Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with CUTIVATE Cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
CLINICAL STUDIES
Psoriasis Studies: In 2 vehicle-controlled studies, CUTIVATE Cream applied twice daily was significantly more effective than the vehicle in the treatment of moderate to severe psoriasis. The investigator's global evaluation after 28 days of treatment is shown in Table 3.
Table 3. Physician's Assessment of Clinical Response
|
|
CUTIVATE Cream
|
Vehicle
|
Study 1
(n = 59)
|
Study 2
(n = 74)
|
Study 1
(n = 66)
|
Study 2
(n = 75)
|
|
Cleared
|
8%
|
1%
|
3%
|
1%
|
|
Excellent
|
29%
|
28%
|
11%
|
17%
|
|
Good
|
27%
|
34%
|
20%
|
28%
|
|
Fair
|
27%
|
15%
|
33%
|
25%
|
|
Poor
|
7%
|
22%
|
24%
|
27%
|
|
Worse
|
2%
|
0
|
9%
|
1%
|
|
The clinical signs of psoriasis were scored on a scale of 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The mean improvements over baseline in the clinical signs at the end of treatment are shown in Table 4.
Table 4. Clinical Signs: Mean Improvements Over Baseline
|
|
CUTIVATE Cream
|
Vehicle
|
|
Study 1
|
Study 2
|
Study 1
|
Study 2
|
|
Erythema
|
1.19
|
1.07
|
0.55
|
0.84
|
|
Thickening
|
1.22
|
1.17
|
0.81
|
0.97
|
|
Scaling
|
1.53
|
1.39
|
0.95
|
1.21
|
|
Atopic Dermatitis Studies: In 2 controlled 28-day studies, CUTIVATE Cream once daily was equivalent to CUTIVATE Cream twice daily in the treatment of moderate to severe eczema. The investigator's global evaluation after 28 days of treatment is shown in Table 5.
Table 5. Physician's Assessment of Clinical Response
|
|
CUTIVATE Cream Once Daily
|
CUTIVATE Cream Twice Daily
|
Study 1
(n = 64)
|
Study 2
(n = 106) |
Study 1
(n = 65)
|
Study 2
(n = 100) |
|
Cleared
|
30%
|
20%
|
48%
|
21%
|
|
Excellent
|
42%
|
32%
|
32%
|
50%
|
|
Good
|
17%
|
26%
|
5%
|
12%
|
|
Fair
|
3%
|
14%
|
6%
|
10%
|
|
Poor
|
5%
|
3%
|
8%
|
4%
|
|
Worse
|
3%
|
6%
|
2%
|
3%
|
|
The clinical signs and symptoms of atopic dermatitis were scored on a scale of 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The mean improvements over baseline at the end of treatment are shown in Table 6.
Table 6. Clinical Signs and Symptoms: Mean Improvements Over Baseline
|
|
CUTIVATE Cream Once Daily
|
CUTIVATE Cream Twice Daily
|
|
Study 1
|
Study 2
|
Study 1
|
Study 2
|
|
Erythema
|
1.7
|
1.5
|
1.8
|
1.7
|
|
Pruritus
|
2.1
|
1.6
|
2.1
|
1.7
|
|
Thickening
|
1.6
|
1.3
|
1.6
|
1.5
|
|
Lichenification
|
1.2
|
1.2
|
1.2
|
1.3
|
|
Vesiculation
|
0.5
|
0.4
|
0.5
|
0.5
|
|
Crusting
|
0.6
|
0.7
|
0.8
|
0.8
|
|
|
