Clinical trial NCT03332524 (phase 2, status: terminated)
Conditions: sunburn
ICD codes: L55.9, L55.0, L55.1, L55.2
Drugs: sp160412 ibuprofen 400 mg and chlorpheniramine maleate 4 mg, 2 capsules ibuprofen and 1 placebo, capsule chlorpheniramine 4mg and 1 placebo
SMILES: CN(C)CCC(C1=CC=C(Cl)C=C1)C1=CC=CC=N1, CC(C)CC1=CC=C(C=C1)C(C)C(O)=O, CN(C)CCC(C1=CC=C(Cl)C=C1)C1=CC=CC=N1
Reason stopped: 
    sponsor decided to stop for lack of efficacy
  
Eligibility criteria:

        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.