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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
TRIPLE
Enrollment
25
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
Glogau Photodamage Scale: the change between the photodamage grade at Week 4 and Week 8 compared to the photodamage grade at the Baseline Visit.
The Glogau Photodamage Scale (Type I: No wrinkles, Type II: Wrinkles in motion, Type III: Wrinkles at rest, Type IV: Only wrinkles) represents a qualitative assessment to measure the severity of photodamage and wrinkles. Photodamage was graded at the Screening Visit (Day -10 to Day -7), Baseline Visit (Day 0), Week 4 Visit (Day 28), and Week 8 Visit (Day 56). The endpoint that was used to evaluate the primary objective of the study is the delta (change) between the photodamage grade at Week 4 Visit (Day 28) and Week 8 Visit (Day 56) compared to the photodamage grade at the Baseline Visit.
Time frame: 8 weeks
Dryness and Flaking: the change between the dryness grade at Week 4 and Week 8 compared to the dryness grade at the Baseline Visit.
This parameter represents a visual assessment of skin dryness from normal skin (0/no dryness) to very severe dryness (5). Additionally, very marked visual flaking; very coarse scaling; cracking progressing to fissuring; marked thickening may be present.
Time frame: 8 weeks
Dyschromia: the change between the dyschromia grade at Week 4 and Week 8 compared to the dyschromia grade at the Baseline Visit.
This parameter represents a qualitative assessment of skin pigmentation from Normal (grade 0) to Severe (grade 5). Textural features likely to contribute to this grade include both red and brown patches of discoloration and other surface irregularities.
Time frame: 8 weeks
Stinging and Burning: the change between the stinging grade at Week 4 and Week 8 compared to the stinging grade at the Baseline Visit.
This parameter represents an assessment of any stinging or burning and relative duration of the sensation experienced by the subject when questioned by the Expert Grader. A scale of 0 to 5 as noted above can used to describe these findings when present.
Time frame: 8 weeks
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