Oracea Soolantra Association in Participants With Severe Rosacea (ANSWER)

Galderma

Status and phase: Completed; Phase 4

Conditions: Rosacea

Treatments: Drug: Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules; Drug: Ivermectin 1% cream; Other: Oral placebo capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT03075891

RD.03.SPR.113322

Details and patient eligibility

About

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.

Enrollment: 273 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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273 participants in 2 patient groups, including a placebo group

Ivermectin 1% cream + Doxycycline 40 mg MR capsules

Experimental group

Treatment:

Drug: Ivermectin 1% cream

Drug: Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules

Ivermectin 1% cream + Oral placebo capsules

Placebo Comparator group

Treatment:

Drug: Ivermectin 1% cream

Other: Oral placebo capsules