ROBIN MCGRAW REVELATION

STUDY TITLE: Evaluation of Dynamic Infusion Technology™ Acne Cream and Lotion treatment in subjects with mild to moderate acne.

STUDY NUMBER:    RMR 2018-02

Interim Results

Study Basics

  • Number of Subjects: One hundred subjects were enrolled in the phase 2 portion of the study. In a 3:1 Ratio subjects were assigned an active cream or placebo cream (Control Cream)  in conjunction with a lotion. All subjects had the same treatment regimen regardless of cream type.

  • Gender of Subjects: Male and female subjects who are presently using acne cleansers and have oily skin with mild to moderate active acne are enrolled into the study.

  • Racial and Ethnic Origin: Subjects of all racial and ethnic origins within the limitations of the study site have been recruited for the study.

  • Age of Subjects: Subjects between the ages of 18 to 60 have been recruited for the study.

 

IGA Results

  • With approximately half of the subjects completed, these are the interim IGA (Investigator’s Global Assessment) results

  • 57% of subjects showed improvement in IGA scores

  • 34% of the subjects on Active Treatment Cream showed improvement in the IGA scale of at least one grade

  • 23% of the subjects on Control Treatment Cream showed this same improvement

  • There is an 11% greater IGA improvement result on Active Treatment Cream

 

Open Comedone Results

  • 37% of subjects on Active Treatment Cream showed improvement in lesion counts as compared to Control Treatment Cream that showed only 11% improvement

  • Of these, 26% showed greater than 50% improvement in the Active Treatment Cream as compared to 7 % in the Controlled Treatment Arm

  • Of these, 18% in the Active Treatment Arm Showed greater than 75% improvement in lesion counts as compared to 5% in the Controlled Treatment Arm

 

Closed Comedone Results

  • 48% of subjects on Active Treatment Cream showed improvement in lesion counts as compared to Control Treatment Cream that showed only 9 % improvement

  • Of these, 38% showed greater than 50% improvement in the Active Treatment Cream as compared to 4 % in the Controlled Treatment Arm

  • Of these, 20% in the Active Treatment Arm showed greater than 75% improvement in lesion counts as compared to 0 % in the Controlled Treatment Arm


    Papules Results

    • 50% of subjects on Active Treatment Cream showed improvement in lesion counts as compared to Control Treatment Cream that showed only 18 % improvement

    • Of these, 44% showed greater than 50% improvement in the Active Treatment Cream as compared to 11 % in the Controlled Treatment Arm

    • Of these, 23% in the Active Treatment Arm showed greater than 75% improvement in lesion counts as compared to 2 % in the Controlled Treatment Arm


      Pustules Results

      • 5% of subjects on Active Treatment Cream showed improvement in lesion counts as compared to the Control Treatment Cream that showed only 2 % improvement

      • Of these, 5% showed greater than 50% improvement in the Active Treatment Cream as compared to 0 % in the Controlled Treatment Arm

      • Of these, 4% in the Active Treatment Arm showed greater than 75% improvement in lesion counts as compared to 0 % in the Controlled Treatment Arm

      Conclusions 

      The Active Treatment Cream, with the data available today for the 51 completed subjects, shows improvement in all areas studied:

        34% Improvement in IGA results

        37% Improvement in open comedone lesion counts

        48% Improvement in closed comedone lesion counts

        56% Improvement in Papule lesion count

        5% Improvement in Pustule lesion counts

      When comparing the Active Treatment Cream to the Control Treatment Cream there are significantly better results in all categories with the Active Treatment Cream.

       

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