CARNI-RAY RESEARCH TO BEGIN DIAPER RASH WOUND HEALING CLINICALS ON ATP-E

CARNI-RAY RESEARCH TO BEGIN DIAPER RASH WOUND HEALING CLINICALS ON ATP-E amino acid compound by Aug. 15, the East Granby, Conn.-based firm predicted. Carni-Ray Research, a privately held R&D company, submitted a proposed protocol to FDA on June 17 for a study evaluating the "potential for the topical application" of ATP-E to promote "healing of uncomplicated diaper dermatitis in infants." Carni-Ray noted that the study is intended to support a claim that ATP-E promotes healing in "uncomplicated" diaper dermatitis. The firm characterized ATP-E as a "hyperalimentation formula comprised of essential amino acids, but no branched-chain amino acids or adenosine triphosphate." Carni-Ray noted in the proposed protocol that the "rationale for expected accelerated wound healing with ATP-E is that in many instances, wounds lack sufficient vascularity to support the nutritional needs for efficient repair," and "hyperalimentation has the potential for providing those needs." The company added that ATP-E "has been shown safe and effective in promoting wound healing in animals." The diaper rash wound healing trial will evaluate 80 infants between the ages of two and 24 months in a double-blind, randomized fashion using a "paired comparison paradigm for each subject," the protocol says. The study is slated to take place at the Children's Medical Group, a pediatric group practice in Bloomfield, Conn. Potential subjects will be recruited from the practice during regularly scheduled visits. Each subject will be required to have "untreated uncomplicated diaper dermatitis at baseline with a total severity score of at least two on the Jordan Severity Scale," which numerically evaluates the severity of skin integrity, eruptions and erythema. Infants will be excluded if they have a history of allergies, systemic disease or other dermatoses, "complicated" diaper dermatitis, or significant asymmetry of rash. For each potential patient, the pediatrician will determine whether the infant meets the inclusion criteria and then will take a culture of the affected area on each side. A single trained observer/nurse practitioner will evaluate and score the type and severity of the diaper dermatitis at baseline and all time points. The test preparations will include an active control consisting of 25% zinc oxide in a cream-based vehicle. Zinc oxide is the active ingredient in many currently available over-the- counter diaper rash products. Each preparation will be packaged in identical 3 g tubes labeled "baby's left" and "baby's right." Each patient will be treated with 42 tubes of both test and control products, "each clearly labeled as to side," the proposed protocol notes. The ATP-E test product for each batch will be randomly assigned to either the left or right side; side assignments will be balanced, Carni-Ray said. After the nurse practitioner applies the test and control products at baseline, each parent will be instructed to apply the test products at three-hour changing intervals during the day and to keep a log of applications. The severity of the diaper dermatitis will be evaluated and scored by the nurse practitioner for each side at one, two, three and seven days post-baseline. Scores ultimately will be entered into a common database for statistical analysis. At present, no over-the-counter diaper rash products can claim that they "promote healing." However, such claims have been pursued by other OTC firms in addition to Carni-Ray. For example, Pfizer, which markets Desitin Ointment, asked FDA in December 1990 to classify Desitin as Category I (safe and effective) for the claim "promotes healing." Almost one year later, the agency rejected Pfizer's request, maintaining that data submitted by Pfizer did not support the claim. FDA asserted in its June 1990 proposed rule for OTC diaper rash products that "the claim 'promotes healing' has not been demonstrated in clinical studies for any ingredient contained in OTC diaper rash products." The 1990 proposal was culled from four separate tentative final monographs: external analgesics, topical antifungals, topical antimicrobials and skin protectants. In comments on the 1990 proposal, companies including Schering-Plough (A&D Skin Ointment) and Blistex (Dyprotex) argued that "promotes healing" claims should be allowed for diaper rash products. In a December 1992 final rule, FDA determined that all diaper rash claims should be removed from all over-the-counter topical antifungals and external analgesics, effective June 18 ("The Tan Sheet" June 7, In Brief). The agency has indicated that upcoming Federal Register notices will include a final rule for OTC skin protectant drug products for the treatment of diaper rash, a final monograph on external analgesics and a final monograph for topical antifungals. Apart from wound healing in diaper dermatitis, Carni-Ray's ATP-E has previously been tested as a performance-enhancing nutritional supplement and as an antimicrobial wound healing substance. However, for the time being, those indications are not being actively pursued by Carni-Ray. The firm currently sells products to the veterinary market.