treatment of MC in 53 children in a randomized, placebo controlled, blinded protocol with intention-to-treat analysis. Forty eight children completed the study and were available for follow up. The results after 30 days of treatment showed a 90% or greater reduction in the number of visible molluscum lesions in 16 of 19 (84.2%) children treated with the TTO-I preparation versus 1 of 16 (6.2%) and 3 of 18 (16.7%) children treated with iodine or TTO alone, respectively. These results demonstrate the potential efficacy and safety of the combination of TTO and organically bound iodine as a therapeutic modality in treatment of MCV.
Study Protocol
Fifty-three children (mean age 6.3+5.1 years) with MC were enrolled (Table 1). Children were otherwise healthy without major disease, at or above the 50th percentile for height and weight, and met all age-appropriate developmental milestones. Mean length of time with the diagnosis of molluscum was 5.6+5.3 months. Detailed written informed consent was obtained from the parents, and the study protocol was in conformity with the Helsinki Accords regarding human subjects.
The TTO-I preparation contained 75% (v/v) essential oil of Australian M alternifolia (terpinene-4-ol content 40.1%, conforming to Standards Association of Australia, AS 2782-1985), high selenium canola oil, and organically bound iodine in a proprietary formulation (U.S. patent #7,311,928 generously provided by Naturopathix, Inc., Boise, ID) to yield a total iodine concentration in the formulation of 35 micromolar. The preparation contained no preservatives, additives, or solvents. The identical tea tree oil and canola oil were used in the TTO alone group. The iodine alone formulation contained the same organically bound iodine in a vehicle of high selenium canola oil to yield a total iodine concentration in the formulation of 35 micormolar.
Children were randomized to treatment group. Nineteen children were randomized to TTO-I, 18 children to TTO alone, and 16 to iodine alone. Treatment consisted of application of one 4 ul drop to each molluscum lesion twice daily. Treatment was continued for 30 days or until all lesions had resolved if this required less than 30 days. Treatment was considered successful if lesions completely cleared or were reduced in number by greater than 90% by the end of day 30. Parents and physicians were blinded to treatment protocol. Participants were seen every 10 days to monitor progress and assess for adverse events. A mild synthetic lemon fragrance not containing citral was added to scent the iodine olive oil preparation. This fragrance by itself had no therapeutic effect (data not shown).
RESULTS
Forty-eight children were available for follow-up at the end of 30 days. In the TTO-I treated group, 1 child was lost to follow-up; 2 had reductions in the number of lesions but did not meet the 90% criterion; 11 had total resolution of all palpable lesions; and 5 had reductions in the number of lesions greater than 90% at the end of 30 days for a total of 16 of 19 children meeting the study criteria for treatment success. In the TTO alone group, 5 children had some reduction in the number of lesions but did not meet the 90% criterion, and 4 children met the 90% reduction criterion. In the iodine treated group, 2 children withdrew as the parents perceived worsening of the molluscum and sought other treatment, 4 children had spontaneous reduction in the number of lesions but did not meet the 90% reduction criterion, and 1/16 met the 90% reduction criterion. There was variation in the number of molluscum lesions at the end of 30 days in the iodine and TTO groups, with some children having an increase and some a decrease in lesion number.
The treatment was well tolerated and often resulted in a dramatic clearing of visible molluscum lesions (Figures 2 and 3).
The mean number of lesions at enrollment was 22+19 (mean+sem) and did not differ between treatment groups. Lesion number for the entire study population ranged from a minimum of 7 to a maximum of 69, with a median value of 29.
Adverse effects were limited to a small amount of redness around the base of some lesions. Of the 48 children available for follow up, 4 mothers (1 TTO-I, 2 iodine, 1 TTO) reported areas of redness that were concerning to them on a total of 21 molluscum lesions. No area of redness was larger than the 3 mm radius, and no lesion showed signs of infection. No patient discontinued treatment due to adverse reactions. It was not uncommon for parents to report lesions themselves becoming reddened during course of treatment, but no parent reported pain or discomfort in the child from this redness. Parents of 3 children in the TTO-I group and 4 in the TTO group reported a transient sensation of warmth with application, which cleared in approximately 90 sec or less. The difference in incidence of reports of redness around lesions between TTO-I, TTO alone, or iodine was not statistically significant, but both treatment groups had a greater incidence of redness of lesions themselves than the iodine alone group. There was no blistering or other sign of gross cytotoxic effect from application of either TTO-I or TTO alone for the duration of the study. There was no
