Dynamiclear Clinical Trials

The results of the Dynamiclear Phase III Clinical Trials carried out over the last 18 months have been remarkably impressive. Dynamiclear is poised to become one of the leading treatments of choice for anyone affected by the herpes simplex virus. Study Synopsis

STUDY DESIGN:

Multi-center, Prospective Randomized, Comparator-controlled study.

Test product, dose and mode of administration:

Investigational Product (IP): Dynamiclear - Single Dose Topical Application;

1. Cotton swab was immersed in water and lightly squeezed out to remove most of its water,
2.  2-4 drops of IP (depending upon the affected area) was transferred to the cotton swab (enough to saturate it).
3. The cotton swab was then applied to the location of active condition making sure the entire lesion was swabbed thoroughly with Dynamiclear.

Comparator Product:

Five times daily application; "Leading Brand Name" cream was applied on to the affected area.

Safety Determination

The secondary objective was to report the proportion of Dynamiclear patients who develop one or more clinical or laboratory serious drug related adverse experience(s).

In this study no patient experienced any serious adverse experience.

Study Results

Resolution of Vesiculation in the different treatment groups at the end of the study (N=114)

Graph 1:

Vesiculation = The presence of small blisters filled with liquid.
The numbers given in parenthesis ( ) represent percentage

The above Graph details the percentage of patients who were relieved of vesiculation at the end of the study. The vesicles disappeared in 96.6% patients in the Dynamiclear group and in 81.1% patients in the Leading Brand group.

Significant difference was observed and Dynamiclear was found to be more effective for disappearance of Vesiculation (p-value=0.02, one sided).

Resolution of Burning & Stinging Sensation in the different treatment groups at the end of the study (N=114)

Graph 2:

The numbers given in parenthesis ( ) represent percentage

Resolution of symptoms of burning and stinging sensation in different treatment groups at the end of the study. 89.6% patients showed resolution of symptoms in the Dynamiclear group compared to 79.2% in the Leading Brand Name group.

Percentage of patients showing relief in symptom of itching in the treatment groups. (N=96)

Graph 3:

The numbers given in parenthesis ( ) represent percentage

The patients in the Dynamiclear group showed marked improvement in the symptoms and after 48 hrs of single dose application only 68.75 % patients experienced burning and stinging sensation compared to 97.92% patients still experiencing the symptom in the Leading Brand Name group.

Resolution of Erythema in the different treatment groups at the end of the study (N=114)

Graph 4:

Erythema = Redness or inflammation of the skin or mucous membranes.

The numbers given in parenthesis ( ) represent percentage

The data of patients suffering from erythema at the end of the study in the treatment groups is presented in the graph above. 92.6% patients in the Dynamiclear group showed relief in symptoms of erythema and 74% in Leading Brand Name group.

Significant difference was observed and Dynamiclear was found to be more effective for disappearance of Erythema at 5% level of significance (p-value=0.02, one sided).