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Status unknownNCT01828177Updated May 29, 2014

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

A Phase 2 interventional study of PDI-320 and PDI-320 Monad #1 in Rosacea, sponsored by PreCision Dermatology, Inc.. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-29.

Sponsored by PreCision Dermatology, Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rosacea

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Keywords

  • PreCision
  • PDI-320
  • Foam
03

In context

Rosacea

225 studies on the registry are indexed under Rosacea; 19 are open to participants now.

This study's planned enrollment of 200 is above the median of 61 across 195 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

PreCision Dermatology, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    PDI-320

    Foam, twice daily for up to 12 weeks

    Drug: PDI-320

  • Experimental
    PDI-320 Monad #1

    Foam, twice daily for up to 12 weeks

    Drug: PDI-320 Monad #1

  • Experimental
    PDI-320 Monad #2

    Foam, twice daily for up to 12 weeks

    Drug: PDI-320 Monad #2

  • Placebo comparator
    Vehicle

    Foam, twice daily for up to 12 weeks

    Drug: Vehicle

Interventions

  • DrugPDI-320
  • DrugPDI-320 Monad #1
  • DrugPDI-320 Monad #2
  • DrugVehicle
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline and End of Treatment (up to 12 weeks)

  2. Absolute change in inflammatory lesion count

    Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.

    Time frame: Baseline and End of Treatment (up to 12 weeks)

Secondary outcomes

  1. 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.

    Time frame: Baseline, Week 4 and Week 8

  2. Absolute change in inflammatory lesion count (interim time points)

    Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.

    Time frame: Baseline, Week 4 and Week 8

  3. 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)

    Time frame: Baseline and End of Treatment (up to 12 weeks)

  4. 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).

    Time frame: Baseline and End of Treatment (up to 12 weeks)

07

Study locations

2 sites
  • Therapeutics Clinical Research
    San Diego, California, United States
  • Academic Dermatology Associates
    Albuquerque, New Mexico, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01828177
Lead sponsor
PreCision Dermatology, Inc.
Responsible party
Sponsor
First posted
Apr 10, 2013
Start date
Jun 2013
Primary completion
Jun 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
May 29, 2014

Study contacts

Syd Dromgoole, PhD
study director · Therapeutics, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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