Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
Completed · Phase 1
Conditions studied: Healthy
In brief
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.
Key facts
- Study ID
- NCT00864500
- Run by
- Actavis Inc.
- People needed
- 224
- Starts
- 2005-11-01
- Expected to finish
- 2006-02-01
- Last updated by the study team
- 2019-07-09
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Non-tobacco-using female subjects, 18 to 50 years of age, inclusive.
- A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %.
- A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures.
- Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
- Signed and dated informed consent form which meets all criteria of current FDA regulations.
You may not qualify if…
- History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study.
- Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching.
- Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction.
- Presence of a medical condition requiring regular treatment with prescription drugs.
- Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
- Use of any topical dermatological drug therapy (including topical corticosteroids) on the flexor surface of the ventral forearms in the 30 days prior to dosing.
- Use of any tobacco products in the 30 days prior to dosing.
- Receipt of any drug as part of a research study within 30 days prior to initial study dosing.
- Pregnant or lactating.
Where it is running
- Novum Pharmaceutical Research Services — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.