Tazarotene plus UVB .for psoriasis 
Combinatinn plwtotlieraw oj psorias-is 
with tazarotene and UVB 
G. Stinco, G. Bragadin, V De Francesco, A. Frattasio and P. Patrone 
S UM MARY 
The addition of oral retinoids to phototherapy has shown to enhance both the efficacy and rapidity of 
psoriatic lesion clearance when compared to phototherapy alone. Tazarotene is the first available topical 
retinoid developed far the treatment of psoriasis. In the present study, a total of 20 patients with plaque 
psoriasis were randomly assigned to one of the two treatment groups: tazarotene 0.1 % gel plus UVB 
phototherapy or UVB phototherapy alone. During the two months of the study only 1 O patients applied a 
thin film of tazarotene gel 0.1 % to all psoriatic lesions once daily, in the evening. AII patients were exposed 
to UVB three times weekly. Patients were evaluated tor tolerability and globa! response to treatment 
using the Psoriasis Area and Severity lndex (PASI) at days O, 1 O, 20, 30, 40, 50, 60. At baseline the mean 
PASI in the tazarotene plus UVB group was 8.6, while in the other group it was 8.3. At the end of the study 
the mean PASI in the tazarotene plus UVB group was 4.6, while in the other group it was 5.4. AII treatments 
were generally well tolerated and the incidence of undesired side effects was low. 
Background 
Psoriasis is a chronic T-cell-mecliated inflammatory 
skin disease which can be treated w ith topical mecli-
cation , phototherapy or systemic drugs . A subgroup of 
psoriatic patients does not responcl to monotherapy and 
needs a combination therapy. In o ther cases it is the 
doctor who chooses the combination the rapy to reduce 
the doses of each treatment used. The addition of oral 
retinoids to p ho to therapy has shown to enhance both 
the efficacy ancl rapidity of psoriatic lesion clearance 
when compared to phototherapy alone (1) . Tazarotene 
is the first available topical retinoid develop e c.1 fo r the 
treatment of psoriasis . It appears to offer antipsoriatic 
efficacy without many of the toxicity problems related 
to systemic therapy (2, 3). So far no stuclies are avail able 
on the combination therapies with this topic drug . The 
aim of the present stucly was to evaluate the efficacy 
and tole rability o f the combination therapy w ith 
Tazarotene O .1 % gel plus UVB phototherapy comparecl 
to UVB phototherapy alone. 
C linica/ st u dy 
110 acta dermatovenerologica A.P.A. Vol 8, 99, No 3 
Tazarotene plus UVB for psoriasis 
Patients and methods 
A total of 20 patients with plaque psoriasis having a 
Psoriasis Area and Severity Index (PASI) score between 
5 and 15 and aged from 18 to 70 years were enrolled in 
this study. Exclusion criteria included patients treated 
with systemic or topical antipsoriatic drugs in the 
previous 4 weeks, or who had made use of phototoxic 
or photosensitizing drugs; those affected with serious 
cardiac, hepatic and kidney diseases, disorders of the 
hematopoietic system, psychiatric disorders and those 
who had a past history of cancer or progressive cancer 
disease, photodermatitis, or were pregnane women. 
Patients fulfilling the enrolment criteria were 13 males 
and 7 females , aged between 20 and 68 years, mean 
age being 48 years. 
Patients were randomly assigned to one of the two 
treatment groups: 10 patients were treatecl with 
Tazarotene 0.1% gel plus UVB phototherapy ancl 10 
patients unde1went UVB phototherapy alone. The 10 
patients of the first group applied a thin film of 
tazarotene gel 0.1% to all psoriatic lesions once daily in 
the evening, exclucling those on the face, head, flexor, 
and intertriginous areas. All patients were exposed to 
UVB three times weekly. The study lasted 2 months. 
Patients were evaluated for globa! response to treatment 
using the PASI at days O, 10, 20, 30, 40, 50, 60. At baseline 
the mean PASI in the Tazarotene plus UVB group was 
8.6, w hile in the UVB alone group was 8.3. 
Haematological tests ancl ECG were performed on the 
first visit ancl at the check-up at the end of the study. 
Patients were recommendecl not to use other psoriasic 
treatments and to avoicl sun exposure. Use ofhyclrating 
products was allowed. 
The grade of tolerance was estimated on the basis 
of patients' comments and on the survey of the intensity 
of cutaneous irritation signs observecl during clinical 
examinations. Treatment efficacy assessment was 
performed by means of the PASI. Statistical significance 
of PASI recluction relatecl to times was evaluated by 
means univariate and multivariate analysis of variance . 
Results 
An improvement of the clinical picture was observed 
in all patients. The PASI was progressively reduced both 
in the patients who had been treated using the 
combination therapy and in those who had been 
submittecl to the UVB exposure alone (Fig. 1 and Tab. 
1). By the end of the study, in the group of patients 
treatecl with tarazotene plus UVB, the mean PASI 
112 
Clini cal stu dy 
1 EFFICAcvl 
9,00 
8,00 
ti) 7,00 
~ 
C: 
6,00 
5,00 
4,00 
- Tazarotene 
+UVB 
res 3,00 Q) 
:i!: 2,00 
1,00 
0,00 
o 10 20 30 40 50 60 
Days 
Figure 1 . Mean PASI reduction in the 2 study 
groups. 
-o- UVB 
changecl from the initial 8.6 to the fina! 4.6, while the 
mean PASI in the UVB alone group changecl from the 
initial 8.3 to the fina! 5.4 (univariate and multivariate 
analysis of variance: F=l.38 ancl P=0.30). 
No variations worthy of note were observed either 
in the haematological tests or in the ECG. All treatrnents 
were generally well tolerated and the incidence of 
undesired side effects was low. A diffusecl erythema 
was observed in 2 patients on one occasion after UBV 
exposure; 2 patients lamented itching and 1 patient 
reported a burning sensation on the sites of the 
tazarotene gel application. There were no dropouts 
owing to a treatment relatecl adverse event. 
Discussion 
Tazarotene is the first of a new generation of 
acetylenic retinoids, which has proven to be efficacious 
in the treatment of mild-to-moderate plaque psoriasis 
(2, 3). Tazarotene gel is cosmetically acceptable , is 
generally well tolerated ancl is minimally absorbecl 
systemically, with adverse events limited to local 
irritation (2 , 3). Topically applied, in preclinical toxicity 
studies, it was neither teratogenic nor carcinogenic and 
was not sensitizing, phototoxic, or photosensitizing (4, 
5). 
The cosmetic acceptability, the moclest local side 
effects and the absence of systemic adverse events were 
confirmed in the present study. Tazarotene did not 
prove to be phototoxic if applied in the evening before 
UVB exposure . The diminution of the PASI was 
observed to be slightly higher in the group of patient 
acta dermatovenerologica A.P.A. Vol 8, 99, No 3 
Clinical study Tazarotene plus UVB for psoriasis 
Table 1. The variation of PASI observed in the patients examinated. 
Patient Sex Age UVB UVB+ Baseline 10 20 30 40 50 60 
tazarotene PASI PASI PASI PASI PASI PASI PASI 
ZL M 54 * 7 7 6,8 6,3 5,3 5 
CC F 58 * 7,1 8,5 8,9 4,4 4,2 3,9 3 
ML M 57 * 5,1 4,1 3,2 3,4 2,6 2,6 1,2 
SR M 38 6,6 6,8 6,1 5,6 4,6 4,2 
,,.. •. ·m:a·-
BM F 40 8,1 8,6 8,1 7,6 5,2 4,1 
GM M 37 6,4 5,6 6 5,2 5,6 5,2 4,9 -
CV M * 14,2 13,3 14 13,4 13,2 13,2 13,2 
CP M * 11,5 10,8 10,2 10 9,5 8,7 8,6 
<' ~ 
BP M 29 * 14,7 14,2 12,1 10,9 10,2 9,6 8,2 
BR F 20 8,4 7,7 7,2 6,5 6,3 5,2 
CA F 34 • 5,3 4,7 4,3 2,8 2 2 1,4 
ML M 68 14,8 17,2 16,5 12,7 8,2 8 5,7 
LG F 37 * 7,6 7,4 7,8 6,7 5,7 4,3 3,5 
DM M 44 9,4 8,1 8,4 8,2 7,7 7,2 6,8 
SD M 53 * 7,1 7 6,7 6,4 6,2 5,9 5,8 
VD M 36 * 5,2 4,8 4,6 4,2 4,1 3,4 
CR F 39 * 9,9 8,5 6,3 6,8 6 
CM M 7,8 7,2 7,4 5,3 
FD F * 7,3 6,6 5,4 5,1 4,7 
RU M 50 6,8 6,4 5,6 5,1 4,5 4,1 3,4 
who had applied the topic compared to those who had to determine, with the least possible risk of error, 
been treated w ith the phototherapy alone , but the w hether the association of tazarotene gel plus UVB 
difference was not significant . The small sample of phototherapy is a therapy, which opens up new 
patients studied is insufficient to allow us to venture a horizons in the treatment of psoriasis. 
definite judgement on the efficacy of the combination 
therapy compared to the phototherapy alone . We hope Presently, we can only conclude that the addition 
that the performance of a further study using a more of tazarotene to UVB phototherapy seems effective in 
significant number of patients will enable to determine the management of psoriatic lesions. The low incidence 
whether it is possible to reduce both the quantity of the of adverse events seems to suggest that this combination 
topic drug and the dose of the UVB in the combination therapy can be taken into consideration as a possible 
therapy and to observe how long the benefits obtained treatment of psoriasis. 
last once the therapy is suspended. This is the only way 
REFERENCES 
l. Lowe NJ, Pristowsky JH, Bourget T, et al. Acitretin plus UVB therapy for psoriasis. Comparison with 
placebo plus UVB and acitretin alone. J Am Acad Dermatol 1991; 24: 591-4. 
2. Weinstein GD, Krueger GG, Lowe NJ, Duvic M, Friedman DJ, Jegasothy BV, Jorizzo JL, Shmunes E, 
Tschen EH, Lew Kaya DA, Lue JC, Sefton J, Gibson JR, Chandraratna RA. Tazarotene gel, a new retinoid, 
acta dermatovenerologica A.P.A. Vol 8, 99, No 3 ------- --------- - ------------ 113 
Clinical s t udy 
AUTHORS' 
ADDRESSES 
Tazarotene plus UVB fiJr psoriasis 
for topical therapy of psoriasis: vehicle-controlled study of safety, efficacy, and duration of therapeutic 
effect. J Am Acad Dermatol 1997; 37: 85-92. 
3. Weinstein GD. Tazarotene gel: efficacy and safety in plaque psoriasis. J Am Acad Dermatol 1997; 37: 
S33-8. 
4. Marks R. Clinical safety of tazarotene in the treatment of plaque psoriasis. J Am Acad Dermatol 1997; 
37: S25-32. 
5. Chandraratna RA. Tazarotene: the first receptor-selective topical retinoid for the treatment of psoriasis. 
J Am Acad Dermatol 1997; 37: SlZ-7. 
Giuseppe Stinco, MD, dermatologist, Institute ojDermatolo{!,y, D.P.MS.C., 
University oj Udine, Gemona Hospital, 33013 Gemona del Friuli (Udine), 
Italy 
Giovanni Bragadin, MD, same address 
Vincenzo De Francesco, MD, dermatologist, same address 
AlfonsinaFrattasio, MD, dermatologist, same address 
Pasquale Patrone, MD, projessor oj dermatolo{!,y, Head oj Institute, same 
address 
acta dermatovenerologica A.P.A. Vol 8, 99, No 3 ---- ------------- -------- --- - 11J