A phase II multicenter, double-blinded clinical trial of the safety and efficacy of SP160412 in the temporary relief of mild to moderate, (i.e. first degree) sunburn
The objectives of the trial or study, its endpoints, its assumptions and its variables are described below: Objectives and endpoints Study objectives The study intends to determine and compare the safety and synergistic efficacy of the combined dosing of Ibuprofen and Chlorpheniramine maleate vs. each of the individual drugs in subjects with mild to moderate ( 1st degree) sunburn.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
2 Ibuprofen and capsules Chlorpheniramine maleate 3 time per day for 72 hours
Ibuprofen and placebo
Chlorpheniramine 4mg and one capsule Placebo 3/72days
CIDP
Phoenix, Mauritius
Self reported pain score on Pain Numeric Scale (NRS) at each visit
To measure the efficacy of SP160412 in the reduction of pain as reported by the participants. The Brief Pain Inventory - short version assesses pain in the last 24 hours and its impact on daily functioning. It evaluates the worst, the least, the average pain the participants felt during the last day and the actual pain. Scores range from 0 ("no pain") to 10 ("pain as bad as you can imagine"). BPI also evaluates the degree to which pain has interfered with different areas of participants' lives over the past 24 hours: general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven interference items, each of which is scored from zero ("does not interfere") to 10 ("completely interferes"). Finally, BPI also evaluates the amount of relief of pain treatments have provided in the past 24 hours, ranging from 0% ("no relief") to 100% ("complete relief").
Time frame: Twice a day (in the morning and at night) from day 1 to day 5
To measure the efficacy SP160412 combined with a placebo in the reduction of clinical sign of sunburn
To measure the efficacy of SP160412 on Pruritus. 11-point Itch NRS (Appendix I.3. Pruritus Numeric Rating Scale (NRS)); This instrument is presented as a single 11-point numeric scale with scores from 0 to 10, and anchored at 0 representing "No itch" and 10 representing "Worst imaginable itch"
Time frame: Twice a Day (in the morning and at night) from day 1 to day 5
To measure the efficacy of SP160412 for sleep quality
To measure the Sleep quality Scale using The 11-point(NRS)) is an unidimensional patient reported outcome (PRO) for quality of sleep. Participants will on a 11-point numeric rating scale ranging from 0 for "Best possible sleep" to 10 for "Worst possible sleep". Used on a daily basis, sleep diaries are reliable and valid instruments for capturing patient reported outcomes. The sleep quality NRS has good psychometric properties.single-item sleep quality NRS was correlated with pain.
Time frame: once a day in the morning from day 1 to 5
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To evaluate the number of subject with adverse events
To evaluate the Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at evaluate the safety of SP160412 relative to each component alone combined with a placebo based on the incidence of treatment emergent Adverse Events will be recorded in the daily log by the participant and it will be documented at all evaluation visits. Overall incidence of adverse events will be collected for all days of evaluation, from Visit 0 (Day 0) to Visit 6 (Day 8).
Time frame: once a day from Days 2 to 8
Measurement of the evolution of erythema as measured by the Chromameter
To measure the evolution of erythema color by the use of a Chromameter
Time frame: at day one and visit at day 5