A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Natroba™ (spinosad) for the Treatment of Scabies

  • STATUS
    Recruiting
Updated on 7 November 2020

Summary

Clinical research study for the treatment of scabies.

Description

The main purpose of this study is to compare the safety, efficacy, and tolerability of a once-daily topical application of IDP-123 Lotion compared to the IDP-123 Vehicle Lotion in subjects with moderate to severe acne. Subjects must be at least 9 years of age or older and generally healthy. IDP-123 is a lotion containing 0.045% tazarotene for the topical treatment of acne. “Vehicle” is a term to describe a lotion that does not contain any active drug (similar to a placebo). If you decide to be in this research study, you may receive either the IDP-123 Lotion or the IDP-123 Vehicle Lotion. IDP-123 Lotion is called an investigational drug because it has not been approved for sale by the United States Food and Drug Administration (FDA). Because this is a research study, the topical study drug, IDP-123 Lotion, will be given to you only during this study and not after the study is over. 

Assignment to IDP-123 Lotion or IDP-123 Vehicle Lotion will be done randomly, by chance (like tossing a coin). You will have a 50% (1 out of 2) chance of receiving active study lotion and a 50% (1 out of 2) chance of receiving Vehicle Lotion. For this study, all study drug applications will be on the face. 

Participation will be approximately 28 days( including 3 in office visits)

You may receive up to $150.00 if you complete the whole study, as a compensation for your time and travel.

 

Details
Condition Family Practice, Dermatology, Seborrheic dermatitis, ATOPIC DERMATITIS, Healthy People 2010
Clinical Study IdentifierTX154533
Last Modified on7 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

At least one household member must have active scabies infestation
Household members must be 6 or fever and all members must be willing to attend clinic visits
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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