A Study of DER 45-EV Gel to Treat Rosacea (SGTDER45EV)

Sol-Gel Technologies

Status and phase: Completed; Phase 2

Conditions: Rosacea

Treatments: Drug: DER 45 EV; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00940992

SGT DER 45 EV 09

Details and patient eligibility

About

To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, 18 years of age or older
• Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)
• Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA
• Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study

Exclusion criteria

• Subjects who are pregnant, breast feeding, or planning a pregnancy during the study
• Allergy or sensitivity to ingredients in test product
• Any dermatological conditions of the face that may interfere with study evaluations
• Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 3 patient groups, including a placebo group

DER 45 EV Gel, 1%

Experimental group

Description:

DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks

Treatment:

Drug: DER 45 EV

Vehicle

Placebo Comparator group

Description:

Placebo Gel applied topically once a day for 12 weeks

Treatment:

Drug: Vehicle

DER 45 EV Gel, 5%

Experimental group

Description:

DER 45 EV Gel, 5% applied topically once a day for 12 weeks

Treatment:

Drug: DER 45 EV