RxGenesys Independent Study - Princeton ConsumerResearch

A randomized home use study in two parallel groups, consisting of 30 healthy subjects aged 35-70, to assess the efficacy of one anti-wrinkle regimen compared to a placebo regimen.
Barrie Drewitt (Principal Investigator), Danny McCamlie (Project Manager), Reece Statham (Quality Assurance Manager) 
SUMMARY

 

STUDY DESIGN

Double-blind study, using objective instrumental and visual assessments, and subjective perception assessments of 71 healthy subjects with aged skin over a usage period of 8 weeks, to compare the efficacy of one anti-ageing regime compared to a placebo regime using a bi-lateral facial design.

 

TEST GROUPS
  1. Active Regimen – A1 Cleanser, A2 Moisturizer, A3 Illuminator, A4 Anti- Aging

  2. Placebo Regimen – B1 Cleanser, B2 Moisturizer, B3 Illuminator, B4 Anti-Aging

 

DOSE REGIME

Each subject followed a 8-week usage schedule according to the usage instructions provided.

 

DURATION OF STUDY

8 week treatment period, with assessments at Baseline, Week 2, Week 4 and Week 8.

 

NUMBER OF SUBJECTS

71 subjects enrolled onto the study with 68 subjects completing the study.

 

TYPE OF SUBJECTS

Healthy subjects of either sex aged 35 to 70 years who exhibited moderate to advanced photoaging according to the Glogau scale.

 

DURATION OF STUDY

Study Started: w/c 23rd February 2015

Study Ended: w/e 24th April 2015

 

TYPE OF SUBJECTS

Princeton Consumer Research Ltd.

Princeton Forrestal Center

307 College Road EastPrinceton

New Jersey 08540

OBSERVATIONS

Profilometery assessments were taken on all study visits to assess the appearance of fine lines and wrinkles using the generated Silflo replicas of the periorbital area.

 

VISIA photography was taken and analysed by Canfield for assessments of pores.

 

Visual grading according to the Glogau scale of visible photodamage was conducted by a qualified assessor at all study time points.

 

Cutometery assessments of skin firmness and elasticity were conducted using a Courage and Khazaka Cutometer MPA 580.

 

Corneometer assessments of skin moisture content and the humectant properties of the regimes were conducted using a Courage and Khazaka Corneometer CM825.

 

Chromameter assessments of skin tone and skin brightness were conducted using a Courage and Khazaka CR300.

 

Self-perception Questionnaires were issued to each subject as designed by the sponsor to gather subjective opinions of the regimes used.

 

METHOD

At baseline, Informed Consent was obtained and verification of study eligibility was confirmed. Subjects underwent photography and instrumentation measurements/observations, with a subset of 10 subjects undergoing videography. Subjects were provided with the test articles that had been randomly assigned to them and a daily diary card to ensure compliance. Subjects were required to return to the testing facility for additional measurements/assessments on study days 14, 28, and 56.

 

ADVERSE EVENTS
No adverse events were recorded for any subject during the study.
 
CONCLUSION
Following between and within treatment data analysis the following claims have been supported by the study. The full discussion is presented in the results section of this report
RESULTS 
Visible reduction of fine lines and wrinkles

X% reduction by Y days

Visible improvement of skin's firmness and elasticity

X% improvement by Y days

Visible reduction of visible signs of photoaging

X% reduction by Y days

Other Results
  • Visibly increases the appearance of skin smoothness, softness, radiance, firmness, and tone

  • Visibly reduces the appearance of fine lines & wrinkles

  • Improves elasticity over time

  • Skin complexion becomes more luminous and radiant over time

  • Brightens skin tone over time

  • Lightens skin tone over time

  • Promotes even skin tone over time

  • Promotes a glowing complexion over time

  • Maintains and enhances moisturization

  • Moisturizes over time

  • Combats dehydration over time

  • Promotes and maintains optimal hydration levels in the skin

Noticed a reduction in the appearance of deep wrinkles

X% of 32 subjects by Y days

Noticed a reduction in the appearance of fine lines

X% of 32 subjects by Y days

Noticed a reduction in the appearance of age spots

X% of 32 subjects by Y days

Noticed a reduction in the appearance of pores

X% of 32 subjects by Y days

Noticed an improvement in the level of moisture of their skin

X% of 32 subjects by Y days

Noticed a visible improvement of their skin's glow

X% of 32 subjects by Y days

Noticed a visible improvement in their skin's evenness

X% of 32 subjects by Y days

Noticed a visible improvement of their skin's radiance

X% of 32 subjects by Y days

Noticed a visible improvement of their overall complexion

X% of 32 subjects by Y days

Noticed a visible improvement of their skin's elasticity

X% of 32 subjects by Y days

Noticed a visible improvement of their skin's texture

X% of 32 subjects by Y days

Noticed a visible improvement of their skin's softness

X% of 32 subjects by Y days

Demographic Distribution