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Business decision, formulation will not be pursued.
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This study tests two different approaches to the resolution of facial skin resurfacing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Other |
| |
| A | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquaphor | Drug |
| ||
| HP828-101 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician and subject evaluation ratings of the signs and symptoms of facial skin during post-operative care. | 84 Days |
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Inclusion Criteria:
The informed consent document and photography release must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent and photography release document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart.
Subjects 18 years of age or older, scheduled to undergo either a medium chemical peel with 35% TCA or a laser resurfacing. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
Women of child-bearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal) may participate in the study if they meet all of the following conditions:
Adequate birth control methods are defined as: hormonal-topical, oral, implantable, or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or, surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use an adequate birth control method as described above for the remainder of the study.
NOTE: Women who have had a bilateral tubal ligation are not considered to have been surgically sterilized and must agree to the conditions as specified above.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Healthpoint | Study Chair |
| Jeffery Kenkel, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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