Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds
|ClinicalTrials.gov Identifier: NCT01429519|
Recruitment Status : Terminated (Due to slow recruitment)
First Posted : September 7, 2011
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Wound||Drug: RPh201, botanical drug product||Phase 1 Phase 2|
The study objectives are to evaluate safety and efficacy, of topical administration of RPh201 for treatment of patients with hard to heal wounds.
This is to include:
- Safety evaluation of RPh201 (botanical extract) formulated as an oil solution administered topically three times per week during an overall treatment period of up to 4 weeks in patients with hard to heal wounds.
- Efficacy assessment of wound improvement following the use of RPh201 oil solution (botanical extract) administered topically three times per week during an overall treatment period of up to 4 weeks and at the follow-up visit at 3 months after end of treatment in patients with hard to heal wounds
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PRELIMINARY OPEN CLINICAL STUDY, TO ASSESS THE SAFETY AND EFFICACY OF RPh201 APPLIED TOPICALLY FOR THE TREATMENT OF HARD TO HEAL CHRONIC ULCERATED WOUNDS|
|Study Start Date :||December 2011|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Drug: RPh201, botanical drug product
topical, three times per week for a period of 4 consecutive weeks, followed by a single follow up visit 3 months post end of the last treatment day
- To determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 4 weeks, with 52 days follow-up [ Time Frame: 90 days ]
- Safety evaluation - To demonstrate safety using the RPh201 oil solution in terms of skin irritation score to be less than 2 for erythema /edema individual subject's results or less then 1.9 for Primary Irritation Index (PII) category (see section 6.5.2 and APPENDIX 2) .
- Safety evaluation - To demonstrate safety of using RPh201 oil solution in terms of type and severity of adverse events.
- To obtain preliminary data on the efficacy of RPh201 on improving wound status in patients with hard to heal chronic ulcerated wounds [ Time Frame: 90 days ]
- Evaluation of the correlation between the treatment period and changes in wound area size.
- Assessment of wound closure state in terms of % Non-viable area, % granulation tissue appearance,
- Assessment of wound closure state in terms of time to wound closure.
- Assessment of pain based on a pain analog scale of 1-10.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429519
|High Risk Foot Clinic - Maccabi Health Services|
|Principal Investigator:||Eran Tamir, Dr.||High Risk Foot Clinic - Maccabi Health Services Tel Aviv|