PreCision Dermatology Trialling PDI-320

Written by on April 16, 2013 in clinical trials, tetracyclines with 0 Comments

A slightly obscure clinical trial has recently listed, related to treating the lesions and facial blood vessels of rosacea.

The drug mentioned is PDI-320, and the party conducting the trial is Precision Dermatology.

What is PDI-320?

If you look closely at the exclusion criteria, you see that participants are not allowed to have  “previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics or use of the components of PDI-320.”

So this seems to be a pretty bit clue that PDI-320 is some form of oral tetracycline.

If you look for new products relating to Precision Dermatology you find that in April 2012, PreCision acquired Triax Pharmaceuticals, who make an acne treatment called Minocin, which is 50mg or 100mg of minocycline pellets.

The inclusion criteria also mentions “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”, which might alternatively suggest a topical treatment is being investigated. Perhaps something like BenzEFoam – 5% Benzoyl Peroxide foam – lets hope not.

Thirdly Onset Dermatologics, the subsidiary of Precision Dermatology is also responsible for Clarifaom EF, so it is possible that this is the product under trial.

If you find out what PDI-320 is, please post in the comments below, thanks.

Clinical Trial NCT01828177

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

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

Sponsor: PreCision Dermatology, Inc

Primary Outcome Measures:

  • 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).

  • Absolute change in inflammatory lesion count

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

Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014

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Read more about: clinical trials, tetracyclines

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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