- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545970
A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial Lines
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of an Anti-Aging Serum in the Treatment of Facial Lines
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by women with mild to moderate fine lines, wrinkles and overall photodamage on the global face.
Efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8, and 12. Efficacy evaluation on fine lines and wrinkles through clinical grading will also be performed at 15 minutes post product application. Self-assessment questionnaires and VISIA photography will be completed at baseline, weeks 4, 8, and 12. 3D PRIMOS photography will be performed at baseline, weeks 8 and 12.
A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Manhattan Beach, California, United States, 90266
- Ablon Skin Institute Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women between the ages of 35 and 60 years were scheduled for eligibility screening at the study site.
- Women with Fitzpatrick Skin Type I-VI
- Subjects must have mild to moderate global face wrinkles and fine lines
- Subjects may have mild to moderate photo-aging secondary to physiologic aging
- Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must be willing to provide verbal understanding and written informed consent.
Exclusion Criteria:
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects with severe overall photo damage as determined by the Investigator.
- Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
- Subjects who spend excessive time out in the sun.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Anti-aging Serum
Dosage form: Serum composed of water, thickener, and bioactive ingredients including antioxidants and peptides. Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening. Study Duration: 12 weeks. |
Facial cleanser to be used by study participants
Bland moisturizer to be used by study participants after serum in the evening.
Sunscreen to be applied after application of serum in the morning.
Other Names:
|
Placebo Comparator: Placebo Serum
Dosage form: Serum composed of water and thickener. Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening. Study Duration: 12 weeks. |
Facial cleanser to be used by study participants
Bland moisturizer to be used by study participants after serum in the evening.
Sunscreen to be applied after application of serum in the morning.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Efficacy Graded by Griffiths' Scale
Time Frame: 12 weeks
|
The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at Day 28, Day 56 and Day 84 in comparison to baseline indicates an improvement for the indicated parameter.The efficacy parameters will be assessed globally on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome. |
12 weeks
|
Objective Tolerability: scores
Time Frame: 12 weeks
|
The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A decrease in scores or lack of significant increase at Day 28, Day 56 and Day 84 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example for Erythema:Erythema 0 = None No erythema of the treatment area
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Tolerability: scores
Time Frame: 12 weeks
|
The secondary tolerability endpoint will be the Subject Tolerability Assessment of Burning, Itching and Stinging. A decrease in scores or lack of significant increase at Day 28, Day 56 and Day 84 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome. Example Burning. 0 = None No burning of the treatment area
|
12 weeks
|
Self Assessment Questions
Time Frame: 12 weeks
|
The secondary efficacy endpoints will be the Self-Assessment Questionnaire and the Subject Treatment Satisfaction and Ease of Use Questionnaire.
A decrease or increase in response values at Day 28, Day 56 and Day 84 indicates an improvement compared to baseline response values.
Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree).
The best outcome is to Completely Agree with the statement/ question being asked.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Glynis Ablon, MD, FAAD, Ablon Skin Institute Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASIRC-RS-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wrinkles
-
Ulthera, IncTerminatedPeri-oral Wrinkles | Peri-orbital WrinklesUnited States
-
Cynosure, Inc.CompletedPeri-oral Wrinkles | Peri-orbital WrinklesUnited States
-
Anika Therapeutics, Inc.Completed
-
Ivo Pitanguy InstituteAllerganCompleted
-
Home Skinovations Ltd.Completed
-
Pacira CryoTech, Inc., a wholly owned subsidiary...Completed
-
Galderma R&DCompletedCheek WrinklesUnited States
-
Ulthera, IncCompleted
-
Deka Medical, Inc.CompletedWrinkles | RhytidesUnited States
-
Merz North America, Inc.CompletedDécolleté WrinklesUnited States
Clinical Trials on Facial cleanser
-
AllerganCompleted
-
AllerganCompletedPeriorbital HyperpigmentationUnited States
-
Galderma R&DCompletedSkin IrritationUnited States
-
Shari L HandTopMD Skin Care, Inc.TerminatedEczema | Atopic Dermatitis | Hand EczemaUnited States
-
Johnson & Johnson Consumer Inc. (J&JCI)CompletedDermatitis, Atopic | Rosacea | Acne Vulgaris | Sensitive SkinUnited States
-
Ungku Shahrin Medical Aesthetic Research & Innovation...Completed
-
Galderma R&DCompletedAcne Prone SkinUnited States
-
University of MichiganUnilever R&DCompletedSun-Damaged Skin | Retinoid IntoleranceUnited States
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted