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Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Gel) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Mild to Moderate Sunburn Related Symptoms
Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.
Details
| Lead sponsor | Mantecorp Industria Quimica e Farmaceutica Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 124 |
Conditions
- Sunburn
Interventions
- Dexchlorpheniramine 1% gel
- Dexchlorpheniramine 1% cream
Primary outcomes
- Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS) — 7 days
The evaluation of the pruritus will be made by a 10-point visual analog scale, answered by patients at each visit. The sum of weighted scores will be calculated for each sign / symptom in each patient.
Countries
Brazil