Clinical Research

We have many case histories attesting to the therapeutic and cosmetic properties of lotions, gels and creams comprising the OPAL Extracts as the active ingredient.

We have many case histories on the positive effect of OPAL A & OPAL001 on dermal ulcers of all aetiologies.

A clinical trial was conducted at the Quadriplegic Centre in Shenton Park, Perth, Western Australia between November 2003 and June 2004.  All the patients who were treated showed noticeable improvement to what had been non-healing ulcers.

Several reports on the outcomes from treatment of dermal ulcers have been written by medical researchers and clinicians and several papers have been published in Wound Practice & Research, the journal of Wounds Australia.

Professor Geoffrey Mitchell, of the School of Medicine at The University of Queensland, has written a number of reports, conference presentations and published papers on the clinical effects of OPAL A.  Professor Mitchell received approval from the Therapeutic Goods Administration to use OPAL A as an unapproved therapeutic good for the treatment of non-healing venous and pressure ulcers under the Approved Prescriber Scheme. He has had positive results in all the patients that he has treated to date.

Associate Professor Michael Woodward of the University of Melbourne and head of the Wound Clinic at the Heidelberg Repatriation Hospital was also approved to use OPAL A under the Approved Prescriber Scheme.

In January 2010, a Phase II proof-of-concept clinical trial to investigate the safety and efficacy of OPAL A in the treatment of venous and pressure ulcers was commenced at the Heidelberg Repatriation Hospital in Melbourne with Associate Professor Michael Woodward as the principal investigator.

The trial was set up as a randomised, single-blind, placebo-controlled trial, with the placebo consisting of a filtrate and cream derived from the same batch of ripe Carica papaya fruit that had not been subjected to the OPAL process.  Screening in a 4-week Run-in Stage ensured that only truly hard-to-heal ulcers would be admitted to the Randomised Stage of the trial; with any subject that showed significant improvement in the Run-in Stage being excluded from the trial.

This trial was halted at the end of 2010 due to a lack of funding, partly caused by most of the trial subjects responding well to best-practice treatment in the Run-in Stage and thereby being screened out of the Randomised Stage.

The preliminary results of the trial were released in a poster presentation at the biennial Australian Wound Management Association conference at the Gold Coast in May 2014.

We intend to have the trial results publicly released on the completion of a paper that is in the process of being written up.

In 2013 a prospective study was conducted at the Royal Hobart Hospital in Tasmania to obtain further information on the clinical effectiveness of OPAL A, administered as a primary wound dressing, for the treatment chronic ulcers of varying aetiology.  Nine patients attending the Outpatient Wound Clinic at the Hospital with chronic ulcers of varying stages of healing, aetiologies and comorbidities were enrolled.  The results of the study supported the hypothesis that OPAL A may be an effective treatment for chronic wounds.

A second paper is in preparation detailing the results of treatment with OPAL K of an infected stage-4 pressure ulcer of a dying lady in a public hospital in New South Wales.  The patient’s wound had been debrided five times in five weeks immediately prior to the commencement of treatment with OPAL K.  The infection was such that throughout this period the room in the hospital had a very strong odour of rotting flesh.  The use of large amounts of an odour absorbing cream as well as frequent spraying a scented air freshener in the patient’s room and around her bed to mask the odour was unsuccessful.  The most significant effect of the OPAL K treatment was that the malodour disappeared within 24 hours of the first treatment.  The lady died 31 days after the first treatment.

An informal study in a Tasmanian nursing home in 2013 showed that OPAL A Cream had superior outcomes in promoting skin integrity, peripheral circulation and healing of minor wounds compared to Sorbolene.