This study is to assess the efficacy and tolerability of an oral supplement in mild to moderate acne in adult females.
This is a 12-week, single-center, placebo controlled double blind, randomized clinical trial in adult female subjects with mild to moderate non-cystic acne. Female subjects will be enrolled in this single site study to evaluate the efficacy of an oral acne supplement. Upon enrollment, subjects will be randomized to a treatment or a placebo group. Both the subject and the investigator will be blinded to the subject's group allocation. The objective of this research is to assess the efficacy and tolerability of an oral supplement in mild to moderate non-cystic acne in adult females when compared to a placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
102
The Skin Nutraceutical Supplement is made with Nutrafol's patented Synergen Skin Complex®, which is a blend of proprietary formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties combined to synergistically combat the multiple underlying factors that compromise skin health. These ingredients include Holy Basil, Maca, Curcumin, and Berberine in combination with other nutrients used to support skin health such as olive extract (20% hydroxytyrosol), konjac root (3% ceramides), vitamin A, B vitamins, and vitamin C.
A placebo pill containing non-active ingredients
Dermatology Consulting Services
High Point, North Carolina, United States
Change in IGA at 12 weeks
The primary efficacy endpoint is the investigator assessed change from baseline to week 12 in facial acne IGA rating compared to placebo.
Time frame: 12 weeks
Change in IGA at 4 weeks
Investigator assessed change from baseline to week 4 in facial acne IGA rating compared to placebo
Time frame: 4 weeks
Change in IGA a 8 weeks
Investigator assessed change from baseline to week 8 in facial acne IGA rating compared to placebo
Time frame: 8 weeks
Change in corneometry measurements at 4 weeks
Change in corneometry measurements from baseline to week 4 compared to placebo.
Time frame: 4 weeks
Change in sebumeter measurements at 4 weeks
Change in sebumeter measurements from baseline to week 4 compared to placebo.
Time frame: 4 weeks
Change in corneometry measurements at 8 weeks
Change in corneometry measurements from baseline to week 8 compared to placebo.
Time frame: 8 weeks
Change in sebumeter measurements at 8 weeks
Change in sebumeter measurements from baseline to week 8 compared to placebo.
Time frame: 8 weeks
Change in corneometry measurements at 12 week
Change in corneometry measurements from baseline to week 12 compared to placebo.
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Time frame: 12 weeks
Change in sebumeter measurements at 12 week
Change in sebumeter measurements from baseline to week 12 compared to placebo.
Time frame: 12 weeks
Subject assessed improvement at week 4
Subject assessed improvement in using a self assessment questionnaire at week 4 compared to placebo.
Time frame: 4 weeks
Subject assessed improvement at week 8
Subject assessed improvement in using a self assessment questionnaire week 8 compared to placebo.
Time frame: 8 weeks
Subject assessed improvement at week 12
Subject assessed improvement using a self assessment questionnaire at week 12
Time frame: 12 weeks
Product-Related Safety outcomes
Overall incidence of all study product-related adverse events reported during the study.
Time frame: All visits until 12 weeks