An interventional study of Biocellulose Mask and Post Procedure Cream in Skin Smoothness, Radiance and Overall Appearance, sponsored by Revision Skincare. Completed at 1 site in United States. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Revision Skincare · Not applicable, Interventional, and Treatment
This single-center, open-label, clinical case 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 on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. Eleven (11) healthy female subjects completed the clinical study.
This single-center, open-label, clinical case 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 on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial radiance, skin smoothness, and overall appearance 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received a topical facial treatment applied by a license esthetician in a series of 3 sessions at 1 month intervals. The treatment included a topical treatment, biocellulose mask, and serum. Additionally, subjects followed a 12 weeks skincare regimen including a gentle cleanser, bland moisturizer, and bland sunscreen.
Other: Biocellulose Mask · Other: Post Procedure Cream · Other: Gentle Cleanser · Other: Facial Moisturizer · Other: sunscreen
Immediately after treatment, a Biocellulose Mask was applied to the subjects global face for 8 to 10 minutes.
Immediately after treatment and after Biocellulose Mask removal, the Post-Procedure Cream was applied to the subjects global face. Subjects were instructed to apply to the global face from days 1 - 3 post treatment.
Also known as: CMT Post Procedure Cream, Revision Skincare
Subjects were instructed to wash their face with the Gentle Foaming Cleanser twice daily for 12 weeks.
Also known as: Gentle Foaming Cleanser, Revision Skincare
Subjects were instructed to apply the facial moisturizer twice daily to the global face from day 3 after treatment until next study visit.
Subjects were instructed to apply the bland sunscreen to the global face once daily in the morning, with re-application with extended sun exposure per FDA guidelines.
Also known as: Cetaphil® Sheer Mineral Sunscreen SPF 30
Change in Investigator Clinical Efficacy Grading versus Baseline
The primary efficacy endpoint will be favorable analysis of the Investigator Clinical Efficacy Grading of radiance, skin smoothness, and overall appearance using a Modified Griffith's 10-point scale at week 4, week 8, and week 12 versus baseline (0:None, 9=Severe). A reduction in score indicates improvement.
Time frame: 12 weeks
Lack of Significant Change in Investigator Tolerability Parameters versus Baseline
The primary tolerability endpoint will be favorable analysis of Investigator Tolerability grading of erythema, edema and dryness completed by study investigator at baseline, weeks 4, 8 and 12. Local cutaneous tolerability will assessed 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 secondary tolerability endpoint will be favorable analysis of Subject Tolerability grading of burning, itching, and stinging completed by subjects at baseline, weeks 4, 8 and 12. Local cutaneous tolerability will assessed using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.
Time frame: 12 weeks
Clinical Photography: VISIA-CR and Antera 3D
The secondary efficacy endpoint will be favorable analysis of clinical photography including VISIA® and Antera 3D® digital imaging at week 4, 8, and 12 versus baseline. A reduction in visual radiance, skin smoothness, and overall appearance on post-baseline timepoints compared to baseline is indicated 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 favorable analysis of Self-Assessment Questionnaires completed by subjects at baseline, week 4, week 8, and week 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 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
Plan to share: No
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