Relief of pain and erythema associated with superficial sunburn MedDRA version: 8.1 Level: PT Classification code 10042496 Term: Sunburn
Conditions
Interventions
Product Name: diclofenac sodium 1mg/g (0.1%) gel
Pharmaceutical Form: Gel
INN or Proposed INN: diclofenac sodium
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration numb
Sponsors
Novartis Consumer Health SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects to be included in this trial must: - Sign the written informed consent form prior to the enrolment in the trial; - Be in good health, with no abnormal findings in their medical history or on physical examination; - Be aged 18 to 55 years; - Be a male or non-pregnant, non-lactating female. Women of child-bearing potential have to use acceptable methods of contraception which are surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) and sterilized partners by vasectomy or other means. Total abstinence may be considered as acceptable at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study. Women, of non childbearing potential have to meet the following definition of post-menopausal status: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy. - If female, have a negative urine pregnancy test prior to inclusion; - Be covered by the French Social Security system (in agreement with the French legislation: Huriet law n° 88.1138 – 20.12.1988); - Have no dermatologic disorder which could interfere with the study results or increase the risk of adverse events; - Have no skin type providing a skin pigmentation which will not allow discernment of erythema; - Have non tanned skin on the areas to be exposed (back); - Have a phototype II to III (Fitzpatrick’s classification); - Have a normal tolerance to UV and sun. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects to be excluded are those: - Who, if female, is pregnant, planning pregnancy or lactating; - With a known hypersensitivity to diclofenac, aspirin, ibuprofen or other NSAIDs; - Who have used oral or percutaneous therapy during the month preceding the trial, which may interfere with the results of the trial (e.g. corticosteroids, anti-histamines, NSAIDs, any photo-protecting agents or photo-sensitising drugs etc.); - Who received any drug (including any OTC medication) during the week preceding the trial; - Suffering from cutaneous diseases such as psoriasis or active atopic dermatitis, even in sites separated from experimental areas; - Who are prone to photodermatoses or subject with previous occurrence of photoallergy; - Who are immunosuppressed (acquired, congenital or therapeutic); - Suffering from any acute or chronic systemic disease or disorder; - Involved in any investigational protocol within 3 months prior to the trial; - With evidence or history of drug or alcohol abuse; - Who are in the exclusion period in the”Fichier National des Volontaires” of the French Ministry of Health; - Who is a member or relative of the trial site staff or an employee of the trial site or Sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of this trial are to: - compare the efficacy of Diclofenac sodium 1 mg/g (0.1%) gel to vehicle in relieving the spontaneous pain associated with sunburn in the first 24 hours after UV irradiation; - compare the efficacy of Diclofenac sodium 1 mg/g (0.1%) gel to vehicle in relieving the provoked pain with monofilament (monofilament Hoechst) in the first 24 hours after UV irradiation; - compare the efficacy of Diclofenac sodium 1mg/g (0.1%) gel to vehicle in reducing the erythema associated with sunburn in the first 24 hours after UV irradiation; - evaluate the safety (local and general) of Diclofenac sodium 1 mg/g (0.1%) gel. ;Main Objective: The primary objective of this trial is to compare the efficacy of Diclofenac sodium 1 mg/g (0.1%) gel to vehicle in relieving provoked pain (tactile stimulus by gloved finger) associated with sunburn in the first 24 hours after UV irradiation.;Primary end point(s): Provoked pain intensity (tactile stimulus by gloved finger) assessed by the subject on a VAS (0-100 mm) over 24hours. The lower limit (0) indicates no pain and the upper limit (100) indicates severe pain. Tactile pain will be recorded immediately prioir to gel application and at 9 time points after gel apllication. The AUC (0-24) of the change in score from baseline will be calculated for each subject for both the active and its vehicle. | — |
Countries
France
Outcome results
None listed