CompletedNot Applicable

Heat Wrap Device Safety With Age and Body Fat

United States45 participantsStarted 2011-05-05

Plain-language summary

This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Who can participate

Age range18 Years – 84 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2 * or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or \< 30 kg/m2 * Females who are not pregnant or breastfeeding * Subject is medically cleared for study participation Exclusion Criteria: * No sensitivitiy or allergy to device components in contact with skin * Diabetes * Any active skin disease or tattoos at the test site that would affect participation

What they're measuring

Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema)

Timeframe: morning after product wear through 15 days after last product application

Trial details

NCT IDNCT01355653

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07-28

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