NCT02422836

Tolerability and Efficacy of Anti-Aging Treatment Regimen in Subjects With Photodamage

The Tolerability and Efficacy of a Three Product Anti-Aging Treatment Regimen in Subjects With Moderate to Severe Photodamage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: US CosmeceuTechs, LLC · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The subjects will use the test skincare products. This is a full face, twice daily application study, with digital photos and expert grader evaluations at Baseline, 4 and 8 week periods. If the subject meets the study criteria and is enrolled, they will be instructed at screening visit to discontinue the use of any facial products (except dry mineral foundation and eye make-up) for seven (7) days before beginning the study (referred to as the "washout" period). They will return to the site for the baseline visit 2 after the required 7 day washout period (visit can occur within 1 week after screening visit).

Detailed description

After the subjects properly consent to participation and are determined eligible, the study coordinator will review the subjects' medical history and obtain demographics. The Principal Investigator (PI) or designee (expert grader) will examine the subjects to determine their appropriateness for study inclusion. At the Screening visit (Visit 1, Day -10 to -7), the subjects will be assessed by the PI or designee to confirm inclusion into the study. Expert grading and Canfield VISIA CR photographic documentation (all flash modes including RBX) will be performed at baseline (Visit 2, Day 0), Week 4 (Visit 3, Day 28 ± 7 days), and Week 8 (Visit 4, Day 56 ± 7 days). Subjects who, in the PI's or designee's opinion, appear to be experiencing product related adverse reactions may be discontinued at any time during the study. The subjects' home care treatment products (the items included in the kit) will be performed at home, at the times and in the manner described in the instructions provided.

Conditions

• Skin Manifestations

Interventions

Type	Name	Description
OTHER	Three Product Anti-Aging Treatment Regimen	Cream Skin Cleanser RD04033B, twice daily, 8 weeks; Anti-aging Cream RD04034B, twice daily, 8 weeks; and Sunscreen SPF 50 RD04036, once daily, reapply as needed, 8 weeks

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2015-04-21
• Last updated: 2015-04-21