Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging

NCT00974480 | Completed Results

• 1 other identifier: LRP09008
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Facial skin aging is a complex process combining factors such as sun exposure, smoking and those that are believed to be inherited. Changes in the skin over time including decreased thickness result in skin atrophy, wrinkling, sagging, yellowness and changes in pigmentation. Redermic is a cosmetic cream that has been evaluated clinically but not in comparison to tretinoin nor in combination with tretinoin. There is no data on the safety and efficacy of Redermic as compared to topical tretinoin. Rejuva is a cream currently approved by Health Canada for the treatment of photodamaged skin. It contains 0.025% tretinoin one of the most widely studied topical product for skin aging. Studies have shown that topical tretinoin increases collagen synthesis and epidermal thickness thereby improving the appearance of skin aging. The efficacy of Rejuva combined with another topical cosmetic cream such as Redermic in the treatment of skin aging is unknown. One hundred and twenty (120) subjects with signs of skin aging participated in this single-blind study to evaluate the efficacy and tolerance of Redermic versus Rejuva-A™ (0.025% tretinoin) and Redermic in combination with Rejuva-A™ (0.025% tretinoin).

Conditions

Skin Aging

Keywords

Skin; Aging; Rejuva-a; Redermic

Outcome Measures

Primary Outcomes (1)

• Skin Aging Measured With the Photonumeric Scale.

  Scoring was accomplished by matching each part of the face (forehead, glabella, corners of the mouth, nasal labial fold, crow's feet, below eyes and upper lip) to photographs in the scales and reporting the appropriate number in the tables. All individual scores were added to obtain the total score (Less signs of skin aging = 0, more signs of skin aging = 41.6).

  12, 24 weeks

Secondary Outcomes (9)

• Photographic Evaluation by a Panel of Blinded Dermatologists.

  24 weeks

• Trans-epidermal Water Loss (TEWL).

  12, 24 weeks

• Skin Hydration (Conductance)

  12, 24 weeks

• Skin Elasticity.

  12, 24 weeks

• Area Ratio - Analysis of Skin Replicas of Crow's Feet.

  24 weeks

Study Arms (3)

Redermic

EXPERIMENTAL

Cream was applied twice a day every day, morning and evening for 24 weeks.

Other: Redermic

Rejuva-A

ACTIVE COMPARATOR

Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 \& 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, returned to the previous dosage and remained there until the end of study. Hydrating cream was applied to the face in the morning every day for 24 weeks.

Drug: Tretinoin (Rejuva-A)

Combination of Redermic and Rejuva-A

ACTIVE COMPARATOR

Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 \& 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.

Other: Redermic; Drug: Tretinoin (Rejuva-A)

Interventions

Redermic OTHER

Cosmetic cream formulation 609637 43.

Also known as: madescassoside, vitamin C

Combination of Redermic and Rejuva-A; Redermic

Tretinoin (Rejuva-A) DRUG

Tretinoin 0.025% cream.

Also known as: Rejuva-A

Combination of Redermic and Rejuva-A; Rejuva-A

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects are female, between 45 and 55 years of age.
• Females of childbearing potential have had a negative urine pregnancy test prior to randomization.
• Subjects are willing to use adequate contraceptive method or are surgically sterile (including tubal ligation), post-menopausal, abstinent or with a same-sex partner. Adequate means of contraception include; intra-uterine device (IUD) in use for 30 days before Day 0, barrier methods and spermicide in use at least 14 days before Day 0 or oral contraceptive in use for at least 30 days before Day 0.
• Subjects are willing to avoid prolonged exposure to UV radiation for the duration of the study.
• Subjects are capable of giving written informed consent.
• Subjects have changes associated with facial skin aging/photodamaged skin.

You may not qualify if:

• Subjects are male.
• Subjects are pregnant or lactating.
• Subjects have a known allergy to Redermic, Rejuva-A™ or to any component of the tested products.
• Subjects have made use of tretinoin, adapalene, tazarotene or other topical medications for the treatment of facial skin aging during the 12 weeks preceding Day 0.
• Subjects have applied topical alpha hydroxyl acids within 28 days of Day 0.
• Subjects have used or plan to use systemic corticosteroids within 28 days of Day 0 or during the study.
• Subjects have made use of a non-medication topical product directed at improving skin aging during the 28 days preceding Day 0.
• Subjects have a hypersensitivity to any retinoids.
• Subjects have a history of alcohol or drug abuse in the past year.
• Subjects are participating in another interventional study.
• Subjects have had a previous intense pulsed light treatment to the face.
• Subjects have had a previous laser treatment to the face directed at improving skin aging.
• Subjects have the presence of skin diseases such as psoriasis or dermatitis on the face that could interfere with study evaluations.
• Planned or unavoidable exposure to intense ultraviolet (UV) radiation during the study (such as sun tanning salons, vacations in a sunny climate or outdoor worker).
• Subjects have had a botulinum toxin A injection treatment on the face within 2 years of Day 0 or plan to receive this treatment during the study.

Sponsors & Collaborators

• Cosmetique Active International: lead
• Innovaderm Research Inc.: collaborator

Study Sites (1)

Innovaderm Research Inc

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Interventions

Ascorbic Acid; Tretinoin

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Annie Levesque
• Organization: Innovaderm Research Inc

alevesque@innovaderm.ca

514-521-4285

Study Officials

• Robert Bissonnette, MD, FRCPC

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President and Dermatologist

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: September 10, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 20, 2011
• Results First Posted: December 15, 2010

Record last verified: 2011-09

Locations

CA (1)