Clinical Trial of the Safety and Efficacy of SP160412 in the Temporary Relief of Mild to Moderate Sunburn

Phase II Multicenter, Double-blinded Clinical Trial of SP160412 in the Temporary Relief of Mild to Moderate (i.e,First Degree) Sunburn

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.

Inclusion Criteria:

• enter the study, a participant must meet all the following criteria:

  1. Male or female, with a minimum age of 18 years old.

  2. Participant who has experienced sunburn in the past 18 hours before inclusion in the study.

  3. Participant who is willing and able to give written informed consent and understand the language used at the investigation site.

  4. 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.

  5. Participant with a Fitzpatrick skin type I, II or III as clinically defined by the investigator.

  6. 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).

  7. 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.

  8. 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.

  9. Participant who agrees not to expose themself further to the sun and not to apply any topical product (sunscreen, aftersun products, products containing aloe vera, moisturizing products…) on the zone of investigation within 18 hours before sunburn and during the study.

  10. If participant is a woman of childbearing potential and declares to be sexually active, she must have a negative urine pregnancy test (UPT) at inclusion and agree to use an effective form of birth control for the duration of the study (e.g., stable dose of oral contraceptives for at least three months before the start of the study, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal). Abstinence is an acceptable form of birth control for participants who are sexually active.

      Exclusion Criteria:

  1. 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.
  2. Participant who is pregnant or lactating, or is planning to become pregnant during the study.
  3. Participant who is currently enrolled in an investigational product or device study.
  4. Participant who has used an investigational product or investigational device treatment within 30 days prior to the start of the study.
  5. 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.
  6. 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.
  7. 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.
  8. Participant who has used any topical or oral antihistamine/anti-allergy medications within 7 days prior to the start of the study.
  9. 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.
  10. Participant with acute or chronic pain condition.
  11. Participant suffering from asthma.
  12. Participant who has a history of any light-sensitive disorder including but not limited to lupus erythematosus, polymorphous light eruption or porphyria.
  13. Participant with a personal or family history in a first-degree relative of malignant melanoma, dysplastic nevi or non-melanoma skin cancer.
  14. Participant who has received more than one sunburn in the last 6 months in the same zone as the study sunburnt evaluation zone.
  15. Participant who has received sunburn or other erythematous skin reaction to light within 21 days prior to the start of the study.
  16. Participant with extensive body hair, tattoos or other adornment that would make clinical assessments difficult.
  17. Participant who is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the investigator.