Phase II Multicenter, Double-blinded Clinical Trial of SP160412 in the Temporary Relief of Mild to Moderate (i.e,First Degree) Sunburn
Overview
- Phase
- Phase 2
- Intervention
- SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg
- Conditions
- Sunburn
- Sponsor
- Sephoris Pharmaceuticals LLC
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Self reported pain score on Pain Numeric Scale (NRS) at each visit
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •enter the study, a participant must meet all the following criteria:
- •Male or female, with a minimum age of 18 years old.
- •Participant who has experienced sunburn in the past 18 hours before inclusion in the study.
- •Participant who is willing and able to give written informed consent and understand the language used at the investigation site.
- •Participant who is willing and able to administer the investigational medicinal product (IMP) as directed, comply with study instructions and commit to all the follow-up visits for the duration of the study.
- •Participant with a Fitzpatrick skin type I, II or III as clinically defined by the investigator.
- •Participant with a clinical assessment of sunburn score of 2 (mild) or 3 (moderate) according to clinical grading described in Appendix II.
- •Clinical Assessment of Sunburn (page 78).
- •Participant who is in good general health and free of any disease state or physical condition except sunburn that might impair the clinical evaluation of erythema, pain and pruritus associated with sunburn.
- •Participant who confirms not having used sunscreen or any other lotion on the zone of investigation before the acquired sunburn and inclusion in the study.
Exclusion Criteria
- •Participant who routinely subjects himself/herself to natural or artificial tanning or the like which, in the investigator's opinion, exposes the participant to an unacceptable risk when taking part in the study.
- •Participant who is pregnant or lactating, or is planning to become pregnant during the study.
- •Participant who is currently enrolled in an investigational product or device study.
- •Participant who has used an investigational product or investigational device treatment within 30 days prior to the start of the study.
- •Participant with a medical condition (including previous history of cardiac disease, renal disease, gastrointestinal bleeding, uncontrolled hypertension) or a medication which, in the clinical investigator's judgement, makes the participant ineligible or places the participant at undue risk during the study.
- •Participant who has a history of drug allergy or sensitivity to NSAIDs, including Aspirin, and/or to Chlorpheniramine maleate, and/or to any of the components of the IMP.
- •Participant who has used pain relieving and/or analgesic medications (e.g. NSAIDs, ASA, opiates, Tramadol, arnica, products containing aloe vera) or psychoactive substances (e.g. marijuana) within 7 days before the start of the study.
- •Participant who has used any topical or oral antihistamine/anti-allergy medications within 7 days prior to the start of the study.
- •Participant who has used any photosensitizing medication (e.g., topical or systemic retinoids, tetracycline or derivatives, etc.) within 30 days of the start of the study. Estrogens as part of birth control agents or hormone replacement therapy are allowed.
- •Participant with acute or chronic pain condition.
Arms & Interventions
Arm 1 Product SP160412
oral route, 9 doses (Capsule) of SP160412 (Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg combined) in the 72 hours-period from first dose to last dose.
Intervention: SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg
capsules Ibuprofen&placebo
2 capsules Ibuprofen and 1 placebo, oral route, 9 doses of Ibuprofen 400 mg with Placebo (Capsule) in the 72 hours-period from first dose to last dose,
Intervention: 2 capsules Ibuprofen and 1 placebo
Capsule Chlorpheniramin&placebo
capsule Chlorpheniramine 4mg and 1 Placebo, 3/72 hours-period from first dose to last dose, oral route
Intervention: capsule Chlorpheniramine 4mg and 1 Placebo
Outcomes
Primary Outcomes
Self reported pain score on Pain Numeric Scale (NRS) at each visit
Time Frame: Twice a day (in the morning and at night) from day 1 to day 5
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").
Secondary Outcomes
- To measure the efficacy SP160412 combined with a placebo in the reduction of clinical sign of sunburn(Twice a Day (in the morning and at night) from day 1 to day 5)
- To measure the efficacy of SP160412 for sleep quality(once a day in the morning from day 1 to 5)
- To evaluate the number of subject with adverse events(once a day from Days 2 to 8)
- Measurement of the evolution of erythema as measured by the Chromameter(at day one and visit at day 5)