An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea

Rosacea Clinical Trial

Official title:

A Multicenter Randomized Evaluator-Blinded Vehicle-Controlled Parallel Group Evaluation of Twice Daily PDI-320 in Comparison to Its Monads in Adults With Rosacea

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01828177
• Other study ID #: 172-7451-201
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 3, 2013
• Last updated: May 27, 2014
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2014
• Source: PreCision Dermatology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of PDI-320, and the individual components, in adult subjects with rosacea.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has moderate to severe papulopustular rosacea and at least mild erythema and mild telangiectasia.

• Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.

• If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.

Exclusion Criteria:

• Subject is pregnant, lactating or is planning to become pregnant during the study.

• Subject has any other active dermatological condition on the face that may interfere with the conduct of the study.

• Subject has used systemic immunosuppressants within 30 days prior to study start.

• Subject has used systemic retinoids within 6 months prior to study start.

• Subject has used any topical rosacea therapy within 14 days prior to study start.

• Subject has had laser or light therapy on the face within 3 months of study start.

• Subject is currently enrolled in an investigational drug or device study.

• Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article.

• Subject has used vasodilators or adrenergic blocking agents within 6 weeks of study start (except subjects on stable dose for greater than 3 months).

• Subject has active ocular rosacea and/or blepharitis/meibomianitis requiring treatment by an ophthalmologist.

• Subject has previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics or use of the components of PDI-320.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• PDI-320

• PDI-320 Monad #1

• PDI-320 Monad #2

• Vehicle

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
PreCision Dermatology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA)	IGA Score Success Rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and have at least a 2-grade improvement on the IGA score at the End of Treatment. IGA score is used to evaluate the overall severity of rosacea using a 5-point scale from 0 (clear) to 4 (severe).	Baseline and End of Treatment (up to 12 weeks)	No
Primary	Absolute change in inflammatory lesion count	Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.	Baseline and End of Treatment (up to 12 weeks)	No
Secondary	Treatment "Success Rate" based on change in IGA (interim time points)	IGA Score Success Rate is the same as defined in the Primary Outcome Measures.	Baseline, Week 4 and Week 8	No
Secondary	Absolute change in inflammatory lesion count (interim time points)	Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.	Baseline, Week 4 and Week 8	No
Secondary	Change in erythema severity	The investigator will assess the erythema (skin redness) on the entire face, using a grading scale from 0 (none) to 4 (very severe)	Baseline and End of Treatment (up to 12 weeks)	No
Secondary	Change in telangiectasia severity	The investigator will assess telangiectasia (small dilated blood vessels near the surface of the skin) on the face, using a grading scale of 0 (none) to 3 (severe).	Baseline and End of Treatment (up to 12 weeks)	No