Sunburn
Conditions
Keywords
Sunburn, Dexchlorpheniramine, Gel, Cream
Brief summary
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.
Interventions
Small amount applied over the lesion twice a day for 7 days
Small amount applied over the lesion twice a day for 7 days
Sponsors
Mantecorp Industria Quimica e Farmaceutica Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours * Compliance of the subject to the treatment protocol * Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old
Exclusion criteria
* Pregnancy or risk of pregnancy * Lactation * Signs of severe sunburn (vesicles, bullae or ulceration) * Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study * History of atopy or allergic diseases * History of allergy to any component of the formulations * Other conditions considered by the investigator as reasonable for non-eligibility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Composite clinical evaluation of erythema, pruritus and burning sensation performed by the investigator using a 4-point scale for each one of the variables (absent, mild, moderate, intense). | 7 days |
Countries
Brazil
Contacts
Primary ContactSérgio Schalka, M.D.
Outcome results
None listed