| Emer 2011174 | Thin layer of pimecrolimus cream 1% was applied twice daily for
4 weeks to the study physician-chosen target eczematous area
located on one side of the body | Topical medical device cream [Eletone (Mission Pharmacal
Company) containing a high lipid content that utilises a
specialised hydrolipid technology; reverse phase formulation of
70% lipids dispersed in 30% outer phase of water] was applied
three times daily for four weeks on the study physician-chosen
symmetrical target eczematous area on the opposite side of the
body | | Patients were instructed not to bath or shower for at least 8
hours after application of the study treatment | | 20 participants | Male or female; aged ≥ 2 years; clear diagnosis
of mild to moderate atopic dermatitis for at least 1 year;
symmetrical target eczematous areas on opposite sides of the
body; PGA of at least ‘mild’ severity for each
selected target area. Females were included if they had a
negative urine pregnancy test at baseline and agreed to use
adequate birth control during the study | (Primary) percentage of subjects achieving a PGA score of clear
(0) or almost clear (1)
(Primary) PGA of target lesions
(0 = clear,
1–5 = increasing
severity)
(Secondary) PGA score changes at each study
visit
(Secondary) Change in TLSS at each visit to assess
the severity of erythema, papulation/infiltration, excoriation
and lichenification (0 = clear,
1–3 = increasing
severity)
(Secondary) Subject's self-assessment
using an IRB-approved 4-point (0–3) scale (half points
not accepted)
(Secondary) Standardised digital
photography
(Secondary) Safety evaluations through
patient history and physical examination
(Secondary)
Adverse events | | 75% of subjects were rated ‘clear’ or
‘almost clear’ by PGA for both medications after
4 weeks: pimecrolimus 15/20 (75%), topical medical device cream
15/20 (75%). Percent improvement of PGA from randomisation:
pimecrolimus 72.50%, topical medical device cream 71.67%
(p = 0.9283). PGA scores
decreased significantly from baseline for both treatments
(p = 0.004). There were no
significant differences between the groups for PGA scores
throughout the study
(p = 0.8236). No cutaneous side
effects were noted | Method of randomisation described. Allocation concealed from
study investigators. Single-blind study as only the study
investigators were blinded. Intention-to-treat analysis not
described but data from all 20 participants were analysed |
| Frankel 2011173 | Ceramide–hyaluronic acid-based emollient foam applied
three times daily on a study physician-chosen symmetrical target
eczematous area on the opposite side of the body to intervention
B for 4 weeks | Pimecrolimus cream 1%. A thin layer was applied twice daily to a
study physician-chosen target eczematous area located on the
opposite side of the body to Intervention A for 4 weeks | | Patients were advised not to bathe or shower for at least 8
hours after application of study treatment. Patients applied
ceramide–hyaluronic acid-based emollient on one side of
the body and pimecrolimus cream on the opposite side for the
same 4 weeks | USA | 30 participants; 28 participants completed the study | Male or female; age > 2 years; clear diagnosis
of mild to moderate atopic dermatitis for at least 1 year with
symptoms on the extremities; symmetrical target eczematous areas
on opposite sides of the body; IGA of at least mild severity for
each selected target area; negative urine pregnancy test and
agreeing to use adequate birth control throughout the study
(females) | PGA (0 = no inflammatory signs of atopic
dermatitis to 5 = severe erythema and
papulation/infiltration with oozing/weeping
TLSS;
erythema, papulation/infiltration, excoriation, lichenification
and scaling using a grading system that ranged from
0 = none to
3 = severe
Participant self-assessment (a
4-point scale ranging from 0 = complete disease
control to 3 = uncontrolled
disease)
Itching severity scale (VAS)
Product
preference at the end of the study
Safety
evaluations
Adverse events | Photography was used to record the location and size of chosen
target areas throughout the study | Both pimecrolimus and ceramide-hyaluronic acid foam showed
efficacy in mild to moderate atopic dermatitis | Method of randomisation and allocation concealment not clearly
reported. Intention-to-treat population not reported.
Single-blind study (investigator) |
| Jensen 2009171 | Pimecrolimus cream 1% applied to the same upper limb twice daily
for 3 weeks | Betamethasone cream 0.1% applied to the same upper limb twice
daily for 3 weeks | | No systemic treatment for atopic dermatitis was allowed.
Emollients and other non-pharmaceutical interventions were
allowed only on non-target lesions and were monitored by the
investigator | Not stated | 15 participants | Adult participants with mild to moderate atopic eczema; target
lesion score of 3–8 (0–12 scale) for both right
and left sides; symmetrical lesions that do not differ by
> 1 point between sides, upper limbs at least
10% affected | pEASI (only upper limbs evaluated)
Participant assessment
of pruritus (VAS 1–10) | | Immunohistochemistry revealed that the enhanced epidermal
proliferation in atopic dermatitis, possibly as a consequence of
inflammation, was reduced by 49% by pimecrolimus. The 74%
reduction of epidermal proliferation by betamethasone may be
considered a suppression exceeding the normal level, possibly
leading to thinning of the epidermis. Both treatments induced
the differentiation markers involucrin, loricrin and
water-binding filaggrin | Data were extracted from the study abstract and therefore trial
information was limited |
| Luger 2001170 | SDZ ASM 981 cream 0.05%, 0.2%, 0.6% and 1.0% applied twice daily
on all affected areas except for the head and neck for up to 3
weeks or until complete clearance if this was sooner | Vehicle cream applied twice daily on all affected areas except
for the head and neck for up to 3 weeks or until complete
clearance if this was sooner | Betamethasone 17-valerate cream 0.1% applied twice daily on all
affected areas except for the head and neck for up to 3 weeks or
until complete clearance if this was sooner | | Multinational (Belgium, Denmark, Finland, Germany, the
Netherlands, Norway, UK) | 260 participants (vehicle
n = 43, ASM 0.05%
n = 42, ASM 0.2%
n = 46, ASM 0.6%
n = 42, ASM 1.0%
n = 45, betamethasone
17-valerate n = 42) | Men and women aged ≥ 18 years who had given
their written informed consent; suffering from atopic dermatitis
according to the diagnostic criteria of Hanifin and Rajka8 of at least
moderate severity according to the Rajka and Langeland228 grading system
and affecting between 5% and 30% of the total body surface
area | Adapted EASI score (excluding head and neck region): erythema,
infiltration or papules, excoriation and lichenification were
assessed on a 4-point scale, with 0 = none,
1 = mild, 2 = moderate,
3 = severe
Pruritus assessed on a 4-point
scale, with 0 = none, 1 = mild,
2 = moderate, 3 = severe;
assessed as the intensity of the itch in the previous 24
hours
Participant-assessed atopic eczema at the end of
the study assessed on a 7-point scale, with
0 = normal or 100% clear,
1 = almost/90–99% clear,
2 = marked improvement or 75–89% clear,
3 = moderate improvement or 50–74%
clear, 4 = slight improvement or 25–49%
clear, 5 = unchanged or < 25%
clear, 6 = worsened
Adverse events | | Betamethasone 17-valerate group had the highest rate of
moderately clear or better participants. SDZ ASM 981 1.0%, 0.6%
and 0.2% creams were significantly more effective than the
vehicle cream. The 0.05% SDZ ASM 981 cream failed to show a
significant effect. The 1.0% SDZ ASM 981 cream showed the
greatest improvement compared with all concentrations of SDZ ASM
981
Betamethasone 17-valerate was more effective than any
SDZ ASM 981 cream concentration in reducing pruritus. SDZ ASM
981 1.0%, 0.6% and 0.2% creams were associated with a greater
increase from baseline to end point in the number of
participants with pruritus rated as ‘absent’ or
‘mild’ compared with vehicle
Participant
assessment of eczema at the end of the study showed a higher
proportion of participants to be moderately clear or better
(> 50% improvement) in the SDZ ASM 981 1.0%,
0.6% and 0.2% cream groups compared with vehicle
All
treatments were less effective in the more severe
participants | Method of randomisation, allocation concealment and blinding not
adequately described |
| Luger 2004172 | Pimecrolimus cream 1% applied to all affected areas twice daily
until complete clearance and itching had stopped, then treatment
restarted if inflammation recurred. Persistent lesions could be
treated while stopping treatment of cleared lesions, for 12
months | Triamcinolone acetonide 0.1% (trunk and limbs) and
hydrocortisone acetate 1% (face, neck and intertriginous areas)
applied to all affected areas twice daily until complete
clearance and itching had stopped, then treatment restarted if
inflammation recurred. Persistent lesions could be treated while
stopping treatment of cleared lesions, for 12 months | | Use of emollients during the study was encouraged. Only
antihistamines allowed as concomitant treatment | Multinational (Belgium, Canada, Denmark, Finland, France,
Germany, the Netherlands, Norway, UK) | 658 participants (pimecrolimus
n = 328, topical
corticosteroids n = 330) | Age 18–79 years; atopic eczema diagnosed according to
the UK Working Party criteria;9 moderate to severe eczema (Rajka
and Langeland228
scale); ≥ 5% of body surface area affected | The primary objective of the study was to investigate long-term
safety and tolerability | | Majority of participants used study treatment continuously over
the 1-year treatment period. In patients with an affected body
surface area > 30%, rate of all skin infections
was significantly lower in the pimecrolimus group (95% Cl of the
treatment difference –25.3% to –3.4%). The most
common application site reaction was burning (transient, mild or
moderate) (pimecrolimus group 25.9%, topical corticosteroids
10.9%. Three participants on topical corticosteroids reported
skin striae. There were no clinically significant systemic or
treatment-related adverse events. Efficacy: better with
continuous topical corticosteroid treatment. Participants who
completed the trial were similarly well controlled in both
groups. There was no topical corticosteroid use in the 1-year
treatment period in 42% of the pimecrolimus group | Method of randomisation and allocation concealment not reported.
Intention to treat not used for the analyses |
