Tolerability and Efficacy of Anti-Aging Treatment Regimen in Subjects With Photodamage

Last updated: April 16, 2015
Sponsor: US CosmeceuTechs, LLC
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02422836
USC-06-13.1
  • Ages 35-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must be diagnosed by the investigator or expert grader to have moderate tosevere lines/wrinkles (Grade 3 or higher, determined by the Glogau Scale).

  2. Subjects must be 35 - 65 years of age with no known medical conditions that, in theinvestigator's opinion, may interfere with study participation.

  3. Sexually active females of childbearing potential participating in the study mustagree to use a medically-acceptable method of contraception while receiving studyproduct. A woman of childbearing potential is defined as one who is biologicallycapable of becoming pregnant; including perimenopausal women who are less than 2 yearsfrom their last menses. Exception: Sexually inactive females of childbearing potentialare not required to practice a reliable method of contraception and may be enrolled atthe investigator's discretion, provided that they understand the possible risksinvolved in getting pregnant during the study and are counseled to remain sexuallyinactive for the duration of the study or to practice a reliable method ofcontraception if becoming sexually active during the study.

  4. Subjects must sign a written informed consent.

Exclusion

Exclusion Criteria:

  1. Any dermatologic disorder, which in the investigator's opinion, may interfere with theaccurate evaluation of the subject's facial skin. Examples of such disorders includesevere acne vulgaris, acne conglobata, acne fulminans, facial seborrheic dermatitis,and lupus erythematosus.

  2. Subjects who have demonstrated a previous hypersensitivity reaction to any of theingredients of the study products.

  3. Concurrent therapy with any medication either topical or oral that might, in theinvestigator's opinion, interfere with the study.

  4. Subjects who are not willing to discontinue their normal facial cosmetics during thestudy period. The subjects' dry mineral foundation and eye make-up are permitted, noliquid foundation; no other facial products other than the provided skincare productsmay be used.

  5. Subjects who have used anti-aging skincare products (cosmetic and drug products withany of the following ingredients: AHA, Salicylic Acid, Vitamins A, Retin-A, Vitamin C,Growth Factors or Peptides, Antioxidants such as Idebenone, CoffeeBerry, CE Ferulic,Phloretin, etc.) within the last 3 months and during the course of the study.

  6. Subjects with recent history in the past 6 months and during the course of the studyof laser, chemical peels, microdermabrasion, or other medical treatments for the skinfor anti-aging.

  7. Subjects who are pregnant, breast feeding or planning a pregnancy during the studyperiod.

  8. Subjects who are unwilling or unable to comply with the requirements of the protocol.

  9. No sun-bathing, use of sun lamps or tanning beds is permitted during the entireduration of the study.

  10. Participation in another research study (currently or within the last 30 days).

  11. All volunteers will sign the consent forms after being informed as to theirobligations and risks that they might encounter as a participant in this study.

Study Design

Total Participants: 25
Study Start date:
February 01, 2013
Estimated Completion Date:
May 31, 2013

Study Description

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.