A Safety and Efficacy Study to Evaluate Rosacea (NCT03883945) | Clinical Trial Compass
WithdrawnPhase 1/2
A Safety and Efficacy Study to Evaluate Rosacea
Stopped: Sponsor deprioritization
United States0Started 2021-07
Plain-language summary
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
Who can participate
Age range18 Years – 65 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:
* Healthy male and/or female subjects between the ages of 18 and 65 year with rosacea, 10 to 30 papules and pustules (at least 5 lesions within the treatment area on each facial side), and \< 2 nodules
* Presence of moderate to severe persistent erythema
* Total body weight \>45 kg
Exclusion Criteria:
* Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea
* Extremely dark skin type that would confound the digital analysis of erythema (eg, Fitzpatrick Skin Type 5 or 6)
* Excessive facial hair (eg, beards, sideburns, moustaches, etc.), birthmarks, or tattoos that would interfere with diagnosis or assessment of rosacea
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to start of treatment.
* Hypersensitivity or allergy to axitinib or any other component of the study treatment
* Use within 6 months prior to baseline and during the study of oral retinoids (eg, Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
* Use within 6 weeks prior to baseline and during the study of vasodilators or α-adrenergic receptor-blocking agents.
* Use within 1 month prior to baseline and during the study of 1…