Oracea Soolantra Association in Patients With Severe Rosacea



Status:Active, not recruiting
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/14/2018
Start Date:July 5, 2017
End Date:February 15, 2018

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Efficacy Comparison of Ivermectin 1% Topical Cream Associated With Doxycycline 40 mg Modified Release (MR) Capsules Versus Ivermectin 1% Topical Cream Associated With Placebo in the Treatment of Severe Rosacea

The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream
associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical
cream associated with Placebo in the treatment of severe Rosacea.


Inclusion Criteria:

- Male or female subject age ≥ 18 years or older;

- Subject with a minimum of 20 but not more than 70 inflammatory lesions (papules and
pustules) of rosacea on the face at Baseline visit;

- Subject with severe rosacea with papulopustular lesions (according to the
Investigator's Global Assessment, IGA score rated 4);

- Female subjects of childbearing potential with a negative urine pregnancy test (UPT);

- Female subjects of childbearing potential must practice a highly effective method of
contraception during the study;

Exclusion Criteria:

- Subjects with particular forms of rosacea or other concomitant facial dermatoses that
may be confounded with rosacea;

- Subjects with more than 2 nodules of rosacea on the face;

- Subjects with any uncontrolled chronic or serious disease or medical condition that
may either interfere with the interpretation of the clinical trial results, or with
optimal participation in the study or would present a significant risk to the subject;

- Subjects with known or suspected allergies or sensitivities to any component of the
investigational and non-investigational products, including the active ingredients
doxycycline and ivermectin;
We found this trial at
9
sites
4242 Farnam Street
Omaha, Nebraska 68144
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Omaha, NE
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1500 Northwest 10th Avenue
Boca Raton, Florida 33486
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Boca Raton, FL
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6100 Massard Road
Fort Smith, Arkansas 72916
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Fort Smith, AR
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9640 West Tropicana Avenue
Las Vegas, Nevada 89148
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Las Vegas, NV
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214 South 8th Street
Louisville, Kentucky 40202
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Louisville, KY
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377 Church Street
Markham, L6B 1A1
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Markham,
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654 Brockenbraugh Court
Metairie, Louisiana 70001
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Metairie, LA
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1202 Farm to Market 685
Pflugerville, Texas 78660
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Pflugerville, TX
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5030 J Street
Sacramento, California 95819
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Sacramento, CA
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