An interventional study of Gentle Cleanser and Facial Moisturizer in Fine Lines, Wrinkles and Laxity; Skin, sponsored by Revision Skincare. Completed at 1 site in United States. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Revision Skincare · Not applicable, Interventional, and Treatment
This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. Thirty-two (32) healthy female subjects completed the clinical study.
This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity.
The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial fine lines, wrinkles, and laxity. was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.
Revision Skincare is the lead sponsor of 18 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects received a topical facial treatment applied by a license esthetician in a series of 3 sessions at 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks.
Other: Gentle Cleanser · Other: Facial Moisturizer · Other: sunscreen SPF 30
The cleanser was instructed to be used twice daily over the course of 12 weeks
Also known as: Gentle Foaming Cleanser, Revision Skincare
The Moisturizer was instructed to be applied to the global face twice daily over the course of 12 weeks.
The Sunscreen was instructed to be applied once daily in the morning, with re-application with extended sun exposure per FDA guidelines over the course of 12 weeks.
Also known as: Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 30
Change Investigator Clinical Efficacy Grading versus Baseline
The primary efficacy endpoint will be Investigator Clinical Efficacy grading of parameters at baseline, post-application, and weeks 4, 8, and 12. the efficacy parameters will be assessed by the expert grader on each subjects global face using a modified Griffiths 10-point scale. A decrease in score indicates an improvement.
Time frame: 12 weeks
Lack of significant change in Investigator Tolerability Parameters versus Baseline
The primary tolerability endpoint will be Investigator Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by the expert grader by assessing the signs of erythema and dryness using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.
Time frame: 12 weeks
Lack of significant change in Subjective Tolerability versus Baseline
The primary tolerability endpoint will be Subjective Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by subject reporting of the degree of burning, stinging, and itching globally on each subject's global face using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.
Time frame: 12 weeks
Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement
The secondary endpoint will be subject self-assessment questionnaire completed at baseline, post-application, and weeks 4, 8, and 12. Subjects are asked to rate statements based on a scoring system ranging from 5 (completely agree) to 1 (completely disagree). A change in response values at post-application, and weeks 4, 8, and 12 compared to baseline response values indicates an improvement. The best outcome is to Completely Agree with the statement / question being asked.
Time frame: 12 weeks
Clinical Photography: VISIA-CR and Antera 3D
The secondary endpoint will be image analysis of VISIA-CR and Antera 3D clinical photography. VISIA-CR imaging analysis for nasolabial folds, and Antera imaging analysis of roughness and volume on images taken at all timepoints. a reduction in visual fine lines, wrinkles, radiance, and laxity on post-baseline timepoints compared to baseline is indicated an improvement
Time frame: 12 weeks
Plan to share: No
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Cutis Laxa
Revision Skincare