Tags

Type your tag names separated by a space and hit enter

High efficacy of a dimeticone-based pediculicide following a brief application: in vitro assays and randomized controlled investigator-blinded clinical trial.
BMC Dermatol. 2019 10 18; 19(1):14.BD

Abstract

BACKGROUND

Increasing resistance of head lice against neurotoxic agents and safety concerns have led to the search for treatment alternatives. Dimeticones with a physical mode of action are safe, and bear a reduced risk for the development of resistance.

METHODS

We performed in vitro bioassays to assess pediculicidal and ovicidal activities of a new dimeticone-based product, and a randomized controlled clinical trial to assess efficacy, following 10 min application. Of 153 individuals screened, 100 participants with active head louse infestations were randomly assigned to treatment with either a dimeticone-based test product, or a 0.5% permethrin-based reference product (50 participants per group). Participants received two topical applications of either the test (10 min) or reference products (45 min) at days 0 and 7 or 8. Outcome measures included the efficacies of treatment and their safety, as well as global and local tolerability at baseline, and days 1, 7, and 10.

RESULTS

After 10 min exposure, all lice treated with the dimeticone test product were classified as non-viable in the in vitro assay. Ovicidal activity after treatment of eggs with the dimeticone test product was 96.8%. In the clinical trial, 96 patients completed all study visits. In the full analysis set (FAS) population, on day 1 after one application, 98% of patients were cured in the test group, as compared to 84% cured in the reference group. All participants in both groups were free of head lice on day 10, following two applications (100% cure rate). In total, 42 adverse events (AEs) in 23 patients of both treatment groups were recorded, with the majority of AEs classified as mild.

CONCLUSIONS

We have shown a high level of pediculicidal and ovicidal activity, and clinical efficacy and safety, of a brief application of a new dimeticone-based product. The short application time and reduced risk for the development of resistance are key drivers for improved patients' compliance.

TRIAL REGISTRATION

EU Clinical Trials Register EudraCT 2016-004635-20 . Registered 14 November 2016.

Authors+Show Affiliations

Department of Community Health, School of Medicine, Federal University of Ceará, Rua Professor Costa Mendes 1608, 5. andar, Fortaleza, CE, 60430-140, Brazil. heukelbach@web.de.CardioSec Clinical Research GmbH, Dalbergsweg 21, 99084, Erfurt, Germany.Department of Veterinary & Animal Sciences, Massachusetts Pesticide Analysis Lab, University of Massachusetts Amherst, Amherst, MA, 01003, USA.IS Insect Services GmbH, Motzener Straβe 6, 12277, Berlin, Germany.G. Pohl-Boskamp GmbH & Co. KG, Kieler Straβe 11, 25551, Hohenlockstedt, Germany.

Pub Type(s)

Equivalence Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31647007

Citation

Heukelbach, Jorg, et al. "High Efficacy of a Dimeticone-based Pediculicide Following a Brief Application: in Vitro Assays and Randomized Controlled Investigator-blinded Clinical Trial." BMC Dermatology, vol. 19, no. 1, 2019, p. 14.
Heukelbach J, Wolf D, Clark JM, et al. High efficacy of a dimeticone-based pediculicide following a brief application: in vitro assays and randomized controlled investigator-blinded clinical trial. BMC Dermatol. 2019;19(1):14.
Heukelbach, J., Wolf, D., Clark, J. M., Dautel, H., & Roeschmann, K. (2019). High efficacy of a dimeticone-based pediculicide following a brief application: in vitro assays and randomized controlled investigator-blinded clinical trial. BMC Dermatology, 19(1), 14. https://doi.org/10.1186/s12895-019-0094-4
Heukelbach J, et al. High Efficacy of a Dimeticone-based Pediculicide Following a Brief Application: in Vitro Assays and Randomized Controlled Investigator-blinded Clinical Trial. BMC Dermatol. 2019 10 18;19(1):14. PubMed PMID: 31647007.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High efficacy of a dimeticone-based pediculicide following a brief application: in vitro assays and randomized controlled investigator-blinded clinical trial. AU - Heukelbach,Jorg, AU - Wolf,Doerte, AU - Clark,John Marshall, AU - Dautel,Hans, AU - Roeschmann,Kristina, Y1 - 2019/10/18/ PY - 2019/04/25/received PY - 2019/09/20/accepted PY - 2019/10/25/entrez PY - 2019/10/28/pubmed PY - 2020/4/14/medline KW - Body lice KW - Clinical trial KW - Dimeticone KW - Head lice KW - Ovicidal activity KW - Pediculicidal activity SP - 14 EP - 14 JF - BMC dermatology JO - BMC Dermatol VL - 19 IS - 1 N2 - BACKGROUND: Increasing resistance of head lice against neurotoxic agents and safety concerns have led to the search for treatment alternatives. Dimeticones with a physical mode of action are safe, and bear a reduced risk for the development of resistance. METHODS: We performed in vitro bioassays to assess pediculicidal and ovicidal activities of a new dimeticone-based product, and a randomized controlled clinical trial to assess efficacy, following 10 min application. Of 153 individuals screened, 100 participants with active head louse infestations were randomly assigned to treatment with either a dimeticone-based test product, or a 0.5% permethrin-based reference product (50 participants per group). Participants received two topical applications of either the test (10 min) or reference products (45 min) at days 0 and 7 or 8. Outcome measures included the efficacies of treatment and their safety, as well as global and local tolerability at baseline, and days 1, 7, and 10. RESULTS: After 10 min exposure, all lice treated with the dimeticone test product were classified as non-viable in the in vitro assay. Ovicidal activity after treatment of eggs with the dimeticone test product was 96.8%. In the clinical trial, 96 patients completed all study visits. In the full analysis set (FAS) population, on day 1 after one application, 98% of patients were cured in the test group, as compared to 84% cured in the reference group. All participants in both groups were free of head lice on day 10, following two applications (100% cure rate). In total, 42 adverse events (AEs) in 23 patients of both treatment groups were recorded, with the majority of AEs classified as mild. CONCLUSIONS: We have shown a high level of pediculicidal and ovicidal activity, and clinical efficacy and safety, of a brief application of a new dimeticone-based product. The short application time and reduced risk for the development of resistance are key drivers for improved patients' compliance. TRIAL REGISTRATION: EU Clinical Trials Register EudraCT 2016-004635-20 . Registered 14 November 2016. SN - 1471-5945 UR - https://www.unboundmedicine.com/medline/citation/31647007/High_efficacy_of_a_dimeticone_based_pediculicide_following_a_brief_application:_in_vitro_assays_and_randomized_controlled_investigator_blinded_clinical_trial_ DB - PRIME DP - Unbound Medicine ER -