Clinical Trial of the Safety and Efficacy of SP160412 in the Temporary Relief of Mild to Moderate… (NCT03332524) | Clinical Trial Compass
TerminatedPhase 2
Clinical Trial of the Safety and Efficacy of SP160412 in the Temporary Relief of Mild to Moderate Sunburn
Stopped: Sponsor decided to stop for lack of efficacy
Mauritius80 participantsStarted 2018-01-15
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.2. 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.
✕
What they're measuring
1
Self reported pain score on Pain Numeric Scale (NRS) at each visit
Timeframe: Twice a day (in the morning and at night) from day 1 to day 5
. 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.