|
Treatment
|
Frequency of application |
Design of study
& duration of treatment |
n |
Proportion (%) of subjects with
treatment-related adverse events |
Specific treatment-related adverse events and proportion (%) affected |
Proportion (%) withdrawn due to treatment-related adverse events |
Trial |
|
Desonide lotion 0.05% |
tid |
C, D-B, R; 3 wk |
30 |
3.3 (5.0) |
Stinging: 3.3 (5.0) |
0 (10) |
Greenspan, 1993 |
|
Clobetasol propionate 0.05% cream |
tid |
C, D-B, R, M; 2 wk |
57 |
3.5 |
Burning: 3.5 Skin atrophy: 0 |
0 |
Jegasothy, 1985 |
|
Betamethasone valerate cream 0.1% |
bid |
C, D-B, R; 4 wk |
179 |
4.0 |
Pruritus: 1.0 Burning: 2.0 Psoriasis exacerbation: 0.5 Folliculitis: 0.5 |
0 |
Callen, 1996 |
|
Fluticasone propionate cream 0.05% |
bid |
C, D-B, R; 4 wk |
171 |
4.5 |
Pruritus: 3.0 Burning: 0.5 Dryness: 1.0 |
0 |
Callen, 1996 |
|
Tacalcitol ointment (4 íg/g) |
qd |
C, R, M; 8 wk
|
42 |
4.8 |
Irritation: 2.4 Erythema: 2.4 Pigmentation: 0 |
** |
Farkas, 1999 |
|
Calcitriol ointment (3 íg/g) |
bid |
C, R 8 wk |
60 |
5.0 |
Skin irritation: 5.0 |
0 |
Hutchinson, 2000 |
|
Fluocinonide cream 0.05% |
tid |
C, D-B, R, M; 2 wk |
57 |
5.3 |
Burning: 5.3 Skin atrophy: 0 |
0 |
Jegasothy, 1985 |
|
Betamethasone dipropionate cream 0.05% (augmented) |
qd |
C, R, M; 2 wk |
123 |
5.7 |
Pruritus: 1.6 Stinging: 0.8 Dermatitis: 0.8 Viral infection: 0.8 URI: 0.8 |
0 |
Ellis, 1989 |
|
Fluticasone propionate ointment 0.005% |
bid |
CT, D-B, R, M; 4 wk |
193 |
6.7 (6.3) |
Burning and/or pruritus : 6.0 (6.0) Hypertrichosis: 0.5 |
0 (0) |
Olsen, 1996 |
|
Desonide cream 0.05% |
tid |
C, D-B, R; 3 wk |
30 |
6.7 |
Stinging: 3.3 Erythema: 3.3 |
0 |
Greenspan, 1993 |
|
Fluocinonide ointment 0.05% |
bid |
C, D-B, R, M; 6 wk |
57 |
7.1 |
Pruritus: 1.8 Stinging: 1.8 Psoriasis exacerbation: 3.6 Acne: 1.8 |
1.8 |
Bruce, 1994 |
|
Fluocinonide cream 0.05% |
bid |
C, R, M; 12 wk |
113 |
9.0 |
Pruritus: 1 Burning: 7 Erythema: 1 |
2 |
Lebwohl, 1998 |
|
Fluocinonide cream 0.05% |
bid |
C, R, M; 2 wk |
121 |
9.1
|
Pruritus: 2.5 Stinging: 0.8 Pain: 0.8 Application site rxn: 0.8 Headache: 0.8 Fever: 0.8 Viral infection: 1.7 URI: 0.8 Follicular rash: 0.8 |
2.5 |
Ellis, 1989 |
|
Calcipotriene* ointment 0.005% |
bid |
C, D-B, R; 4 wk |
63 |
9.5 |
Lesional pruritus/burning: 9.5 |
1.6 |
Salmhofer, 2000 |
|
Mometasone furoate 0.1% ointment |
bid |
C, D-B, R,M; 3 wk |
205 |
10 |
Application site reaction: 8 Skin atrophy: 2.4 |
1.0 |
Koo, 1998 |
|
Betamethasone valerate ointment (1 mg/g) |
bid |
C, D-B, R, M; 6 wk |
204 |
10.3 |
Lesional/perilesional irritation: 3.9 Irritation of face/scalp: 0.0 Erythema/desquamation: 1.5 Skin infection: 2.5 Misc. skin problems: 1.0 Nondermatologic: 1.5 |
1.5 |
Cunliffe, 1992 |
|
Calcipotriene* ointment (50 íg/g) |
bid |
C, D-B, R, M; 8 wk |
145 |
11.7 |
Pruritus: 1.4 Rash: 7.6 |
3.4 |
Veien, 1997 |
|
Mometasone furoate 0.1%/salicylic acid 5% ointment |
bid |
C, D-B, R,M; 3 wk |
203 |
12 |
Application site reaction: 9 Skin atrophy: 3.0 |
0.5 |
Koo, 1998 |
|
Calcipotriene* ointment (CP) 0.005% / Diflucortolone valerate ointment 0.1% (DV) |
CP: q am DV: q pm |
C, D-B, R; 4 wk |
63 |
12.7 |
Lesional pruritus/burning: 12.7 |
0 |
Salmhofer, 2000 |
|
Tacalcitol ointment (4 íg/g) |
qd |
C, D-B, R, M; 8 wk |
142 |
12.7 |
Pruritus: 7.0 Rash: 7.7 |
2.8 |
Veien, 1997 |
|
Mometasone furoate 0.1% ointment |
bid |
C, D-B, R, M; 3 wk |
135 |
13 |
Pruritus: <1.0% Burning: 1.0 Skin atrophy: <1.0% |
0 |
Katz, 1998 |
|
Tazarotene gel 0.05% |
qd |
C, D-B, R,M; 8 wk |
52 |
13 |
Pruritus/ Burning/ Erythema
|
3.8 |
Krueger, 1998 |
|
Calcipotriene* cream (CP) (50 íg/g) / Betamethasone 17- valerate cream (BM) (1 mg/g) |
CP: q am BM: q pm
|
CT, D-B, R, M; 8 wk |
175 |
17.1 |
Lesional/ perilesional irritation: 22.9 |
1.7 |
Kragballe, 1998 |
|
Calcipotriene ointment 0.005% |
bid |
C, D-B, R, M; 6 wk |
56 |
17.5 |
Pruritus: 7.0 Burning: 8.8 Erythema: 1.8 Rash: 1.8 Contact dermatitis: 1.8 |
0 |
Bruce, 1994 |
|
Coal tar (5%)/ allantoin (2%)/ hydrocortisone (0.5%) cream |
bid |
C, R, M; 8 wk |
57 |
17.5 |
Pruritus/irritation/burning: 8.8 Erythema: 0 Soreness: 1.8 Rash: 1.8 Psoriasis exacerbation: 1.8 |
5.3 |
Pinheiro, 1997 |
|
Salicylic acid 5%
|
bid |
C, D-B, R, M; 3 wk |
67 |
18 |
Pruritus/ Burning Skin atrophy: 0 |
0 |
Katz, 1998 |
|
Mometasone furoate 0.1%/salicylic acid 5% ointment |
bid |
C, D-B, R, M; 3 wk |
133 |
20 |
Pruritus: 4.0 Burning: 5.0 Skin atrophy: 8.3 |
0 |
Katz, 1998 |
|
Calcipotriene ointment 0.005%
|
bid |
CT, D-B, R, M; 8 wk |
139 |
20.1 (15.2) |
Rash: 10.8 (3.6) Pruritus: 2.2 (2.9) Burning: 2.2 Erythema: 2.9 (Psoriasis exacerbation: 4.3) |
4.3 (5.8) |
Highton, 1995 |
|
Hydrocortisone buteprate 0.1% cream |
bid |
CT, D-B, R, M; 3 wk |
94 |
23
|
Headache: 7.0 URI: 2.0 |
0 |
Sears, 1997 |
|
Calcipotriene* ointment (50 íg/g) |
bid |
C, R, M; 8 wk |
65 |
23.1 |
Pruritus/irritation/burning: 12.3 Erythema: 6.2 Soreness: 1.5 Rash: 0 Psoriasis exacerbation: 1.5 |
1.5 |
Pinheiro, 1997 |
|
Calcipotriene* cream (CP) (50 ug/g) / Clobetasone 17- Butyrate cream (CB) (0.5 mg/g) |
CP: q am CB: q pm |
CT, D-B, R, M; 8 wk |
172 |
23.8 |
Lesional/ perilesional irritation: 29.0 |
1.7 |
Kragballe, 1998 |
|
Calcipotriene* cream, suspended (50 íg/g) |
bid |
CT, D-B, R, M; 8 wk |
161 |
26.1 |
Lesional/perilesional irritation: 10.6 Psoriasis exacerbation: 1.9 Misc. skin problems: 6.8 Nondermatologic: 4.3 |
1.2 |
Harrington, 1996 |
|
Calcipotriene* cream, dissolved (50 íg/g) |
bid |
CT, D-B, R, M; 8 wk |
165 |
27.3 |
Lesional/perilesional irritation: 15.2 Psoriasis exacerbation: 0.6 Misc. skin problems: 4.8 Nondermatologic: 0.6 |
3.6 |
Harrington, 1996 |
|
Tazarotene gel 0.05% |
qd |
C, R,M; 12 wk |
115 |
29 |
Pruritus: 9 Burning: 9 Erythema: 11 |
12 |
Lebwohl, 1998 |
|
Tazarotene gel 0.1%
|
bid |
C, D-B, R,M; 8 wk |
53 |
30 |
Pruritus/ Burning/ Erythema
|
7.5 |
Krueger, 1998 |
|
Calcipotriene* cream (CP) (50 íg/g) / Vehicle (V) |
CP: q am V: q pm |
CT, D-B, R, M; 8 wk |
173 |
31.2 |
Lesional/ perilesional irritation: 37.6 |
4.6 |
Kragballe, 1998 |
|
Calcipotriene* ointment (50 íg/g) |
bid |
C, D-B, R, M; 6 wk |
205 |
33.7 |
Lesional/perilesional irritation: 19.5 Irritation of face/scalp: 2.0 Skin infection: 0.5 Misc. skin problems: 5.4 Nondermatologic: 2.9 |
2.4 |
Cunliffe, 1992 |
|
Calcipotriene* cream (50 íg/g) |
bid |
CT, D-B, R, M; 8 wk |
172 |
34.3 |
Lesional/ perilesional irritation: 51.7 |
3.4 |
Kragballe, 1998 |
|
Calcipotriene* ointment (50 íg/g) |
bid |
C, R, M; 8 wk |
239 |
35.0 |
Burning or lesional/ perilesional irritation: 20.0 Facial erythema or rash: 4.0 |
1.7 |
Berth-Jones, 1992 |
|
Tazarotene gel 0.5%
|
qd |
CT, D-B, R, M; 12 wk |
106 (107) |
39 (15) |
Pruritus: 17 (8) Burning: 15 (6) Erythema: 7 (1) |
10 (3.0) |
Weinstein, 1997 |
|
Dithranol stick
|
qd (30 min.) |
C, R, M; 8 wk
|
42 |
40.5 |
Irritation: 2.4 Erythema: 21.4 Pigmentation: 16.7 |
** |
Farkas, 1999 |
|
Tazarotene gel 0.1%
|
qd |
C, R, M; 12 wk |
112 |
43 |
Pruritus: 18 Burning: 14 Erythema: 11 |
18 |
Lebwohl, 1998 |
|
Tazarotene gel 0.1%
|
Qd |
CT, D-B, R, M; 12 wk |
105 |
50 |
Pruritus: 23 Burning: 19 Ertythema: 8 |
12 |
Weinstein, 1997 |
|
Dithranol cream
|
qd (30 min.) |
C, R, M; 8 wk |
239 |
53 |
Burning or lesional/ perilesional irritation: 48.0 Facial erythema or rash: 0.4 |
5.4 |
Berth-Jones, 1992 |
|
Dithranol cream |
qd (30 min.) |
C, R 8 wk |
54 |
72 |
Skin irritation: 72 |
3.7 |
Hutchinson, 2000 |
qd, once daily; bid, twice daily; tid, three times daily; q am, once in the morning; q pm, once in the evening; CT, controlled trial; C, comparison study; D-B, double-blind study; R, randomized study; M, multicenter study; n, number of subjects included in intention to treat analysis; URI, upper respiratory infection.
Note: For those treatments compared with vehicle, the proportion of subjects with treatment-related adverse events, specific treatment-related adverse events, and proportion withdrawn due to treatment-related adverse events are noted in parentheses within the corresponding row.
*Calcipotriene, the United States Adopted Name (USAN), is substituted for the European name of the vitamin D3 derivative, calcipotriol
**Proportion withdrawn due to treatment-related adverse events not specified