NCT01892423

Brief Summary

Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
Last Updated

July 29, 2022

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

June 26, 2013

Last Update Submit

July 28, 2022

Conditions

Skin Irritation

Outcome Measures

Primary Outcomes (1)

  • Irritation responses

    all patients will be assessed at 14 visits for redness (erythema), spreading, weeping, papules, vesicles, and bullae at application site

    average of 5 weeks

Study Arms (1)

Cetaphil Moisturizing Lotion Daily Advance

EXPERIMENTAL

Each subject had Cetaphil Moisturizing Lotion Daily Advance applied

Other: Cetaphil Moisturizing Lotion Daily Advance

Interventions

Cetaphil Moisturizing Lotion Daily AdvanceOTHER
Cetaphil Moisturizing Lotion Daily Advance

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • Good health
  • willingness to cooperate and participate
  • willingness to avoid topical products at test sites
  • willingness to avoid direct sun exposure to test sites

You may not qualify if:

  • Individuals with active psoriasis or eczema
  • individuals with sunburn, acne, abrasions, scar tissue, or tattoos on test sites, or disease of skin that might interfere
  • individuals who have had a mastectomy with axillary nodes were removed
  • individuals receiving anticancer, immunosuppressive treatments or medications, or radiation
  • pregnant, nursing, or planned to become pregnant
  • use of topical steroids or drugs at test sites
  • active or untreated skin cancer
  • active hepatitis
  • current routine or frequent use of high doses of anti-inflammatory drugs
  • individuals who have had les than two week rest period since completion of previous patch testing on upper back or upper arms
  • individuals with uncontrolled metabolic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas J Stephens and Associates Inc

Carrollton, Texas, 75006, United States

Location

Study Officials

  • James H Herndon, MD, FAAD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 4, 2013

Study Start

August 1, 2006

Primary Completion

September 1, 2006

Last Updated

July 29, 2022

Record last verified: 2013-06

Locations

US(1)