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Status unknownNCT01239719Updated Jan 28, 2011

Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis

A Phase 3 interventional study of Dexamethasone + clemastine and Dexamethasone in Allergy and Dermatitis, sponsored by Azidus Brasil. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-28.

Sponsored by Azidus Brasil · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis.

02

Conditions studied

  • Allergy
  • Dermatitis

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Keywords

  • Allergic dermatitis
03

In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's planned enrollment of 96 is above the median of 64 across 1,131 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who sign the IC in two ways, agreeing with all study procedures
  • Patients aged above 18 years of any ethnicity, class or social group, female or male
  • Patients with acute, subacute or chronic dermatoses, of inflammatory and / or allergic origin, to which it is recommended the use of drugs under investigation, such as:

    • atopic dermatitis
    • prurigo
    • primary contact dermatitis or allergic hives
    • drug eruption
    • allergic vasculitis
    • dyshidrosis, Note: The above clinical conditions are diagnosed from clinical examination.

Exclusion criteria

Exclusion Criteria:

  • Patients being treated with antibiotics
  • Participation in clinical trials in the 12 months preceding the investigation
  • Current treatment with immunosuppressants (eg, cyclosporine or methotrexate)
  • Current treatment with phototherapy (UVA, UVB, PUVA and lasers)
  • Use of systemic corticosteroids in the visit to include or 15 days preceding the survey
  • Topical treatments at the site of lesions in the 15 days preceding the survey
  • Presence of any skin condition
  • Presence of secondary infections at the site of treatment, diagnosed clinically;
  • Presence of other eczematous diseases, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckley's syndrome
  • Pregnant or lactating women
  • Chronic alcoholism
  • Patients with a history of hypersensitivity to any component of the products under investigation.
  • Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.
  • Allergic Dermatosis mild or, acording to the investigator criteria, is not justified systemic treatment.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Dexamethasone + Clemastine

    Dexamethasone + clemastine fumarate cream

    Drug: Dexamethasone + clemastine

  • Active comparator
    Dexamethasone

    Dexamethasone 0.5 mg

    Drug: Dexamethasone

Interventions

  • DrugDexamethasone + clemastine

    Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.

  • DrugDexamethasone

    Dexamethasone 0.5 mg: 01 tablet every 12 hours.

06

What researchers measure

Primary outcomes

  1. Evaluate, through clinical examinations, the effectiveness of the combination tablet with 0.5 mg of dexamethasone and clemastine 1 mg, compared with 0.5 mg tablet of dexamethasone in improving the signs and symptoms associated with allergic dermatitis.

    Evaluating the effectiveness of the polypill dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in improvement of signs (erythema, edema and lesion length) and symptoms (itching) associated with frames of dermatoses allergic.

    Time frame: 14 days of treatment.

Secondary outcomes

  1. Evaluation of the efficacy.

    Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.

    Time frame: 14 days of treatment.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01239719
Lead sponsor
Azidus Brasil
First posted
Nov 11, 2010
Start date
Mar 2011
Primary completion
Jul 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Jan 28, 2011

Study contacts

Alexandre Frederico, Physician
Contact
alexandre@lalclinica.com.br
55 19 3829-3822
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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