Efficacy and Safety of the Association of Dexamethasone 0.5 mg + Clemastine Fumarate 1 mg When Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis
This study has been withdrawn prior to enrollment.
Sponsor:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01125761
First received: May 17, 2010
Last updated: October 25, 2010
Last verified: April 2010
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Purpose
Considering the pathogenesis of several allergic skin diseases to be investigated in this study as well as the pharmacodynamic mechanisms of the association of dexamethasone and clemastine fumarate, it is believed that the components of topical medication may act synergistically in the reduction of signs and symptoms of the diseases in question. Therefore it is expected that the association promotes results significantly superior to dexamethasone alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Dermatitis |
Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream Drug: Dexamethasone 0,5 mg cream |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Clemastine fumarate
Clemastine
U.S. FDA Resources
Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Primary Outcome Measures:
- Through clinical examinations, evaluating the efficacy of the cream composed by 0.5 mg dexamethasone and clemastine 1mg compared with the cream of 0.5 mg dexamethasone in improving the signs and symptoms associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Improvement of the erythema associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Improvement of the edema associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Improvement of the extension of lesion associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis. [ Time Frame: 14 dyas ] [ Designated as safety issue: No ]
- Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 104 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: dexamethasone 0.5 mg and 1.0 mg clemastine cream |
Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
|
| Active Comparator: dexamethasone 0,5 mg cream |
Drug: Dexamethasone 0,5 mg cream
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients who sign the Deed of Consent (IC) in two ways, by his own free will, agreeing with all study procedures;
- Patients older than 18 years, any ethnicity, class or social group, regardless of sex;
- Patients with pictures of dermatoses acute, subacute or chronic, of inflammatory origin and / or allergic, to which it is recommended the use of drugs under investigation topically, such as:
- atopic dermatitis,
- prurigo,
- primary contact dermatitis or allergic
- urticaria,
- pharmacodermic,
- allergic vasculitis,
- dyshidrosis,
Exclusion Criteria:
- Patients being treated with antibiotics;
- Participation in clinical trials in the 12 months preceding the survey;
- Current treatment with immunosuppressants (eg, cyclosporine or methotrexate);
- Current treatment with phototherapy (UVA, UVB, PUVA and lasers);
- Use of systemic corticosteroids at inclusion visit or within 15 days prior to inclusion;
- Topical treatments at the site of acne in the 15 days preceding the visit of inclusion;
- Presence of any skin condition in areas affected by acne that hamper the evolutionary analysis of the lesion;
- Presence of secondary infections at the site of treatment, diagnosed clinically;
- Presence of other eczematous picture, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckley's syndrome Wiskott-Aldrich;
- Pregnant or lactating women;
- Chronic alcoholism;
- Patients with a history of hypersensitivity to any component of the formulas 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 of moderate or severe that, according to the investigator, is not justified topical.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125761
Locations
| Brazil | |
| LAL Clinica Pesquisa e Desenvolvimento Ltda | |
| Valinhos, São Paulo, Brazil, 13276-245 | |
| LAL Clínica Pesquisa e Desenvolvimento Ltda | |
| Valinhos, São Paulo, Brazil, 13276-245 | |
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
More Information
No publications provided
| Responsible Party: | Dr. Alexandre Frederico, L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
| ClinicalTrials.gov Identifier: | NCT01125761 History of Changes |
| Other Study ID Numbers: | DECEMS21209 |
| Study First Received: | May 17, 2010 |
| Last Updated: | October 25, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
|
Allergic dermatitis |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Clemastine Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Antipruritics |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Allergic Agents Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013