check_circleStudy Completed

Dermatitis, Atopic

Bayer Identifier:

Trial_89171

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and tolerance of once-daily methylprednisolone aceponate cream in comparison with twice-daily betamethasone valerate in patients with atopic dermatitis

Trial purpose

A multicenter, open, parallel group comparative study comparing the
therapeutic efficacy and tolerance of methylprednisolone aceponate
(MPA) 0.1% cream once-daily and twice-daily application of
betamethasone valerate (BMV) 0.1% cream in the treatment of
patients of both sexes suffering from atopic dermatitis.

Key Participants Requirements

Sex

All

Age

14 - N/A
  • - Atopic dermatitis, necessity of a therapy with a potent topical
    corticosteroid on a cream base.
    - Age ≥ 14 years

Trial summary

Enrollment Goal
152
Trial Dates
December 1990 - December 1991
Phase
Phase 3
Could I Receive a placebo
No
Products
Advantan (Methylprednisolone Aceponate, BAY86-4862)
Accepts Healthy Volunteer
No

Primary Outcome

  • Physician's overall assessment of therapeutic effect at the end of the treatment period

Secondary Outcome

  • Objective symptoms (erythema, scaling, lichenification, prurigo, rhagades, and excoriation) assessed as severe, mild or absent
  • Subjective complaints (itching, burning, pain) assessed as severe, mild or absent
  • Overall skin condition of diseased areas (graded as very good, good, moderate or bad)

Trial design

Controlled, multicenter trial on efficacy and tolerance of a once-daily application of methylprednisolone aceponate (MPA) cream in comparison with a twice-daily application of betamethasone valerate (BMV) in patients with atopic dermatitis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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