Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Innovaderm Research Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Facial skin aging is a complex and multifactorial process combining extrinsic and intrinsic factors. Major extrinsic factors include sun exposure and smoking while intrinsic factors are believed to be genetically programmed.
Changes in the dermis are responsible for many of the important clinical changes associated with skin aging. With age there is a decrease in the number of fibroblasts and a decrease in their ability to synthesize collagen which results in a decrease in collagen I and II. This is coupled with an increase in matrix metalloproteinases activity. Skin biopsies from elderly volunteers show changes in collagen bundles which become fragmented and disorganized as well as in elastin fibers which are decreased. Changes also occur in the epidermis including a decrease in epidermal thickness and a change in the morphology of keratinocytes of the basal layer. Clinically these changes result in skin atrophy, increased skin laxity, wrinkling, sagging, yellowness and changes in pigmentation.
Redermic is a cosmetic cream containing vitamin C and madecassoside. A preliminary 20 subject split face study has shown that this product was well tolerated and could improve signs of skin aging. To evaluate changes in skin aging this study used a clinical evaluation of the face, skin hydration, the fringe technique, skin biopsies and skin elasticity measurements. The investigators did not perform transepidermal water loss (TEWL), facial skin evaluation using a photonumeric guideline, evaluation of photoaging by panel of blinded dermatologists or skin replica evaluations. There is no data on the combination of Redermic with tretinoin or 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.
The main objective of this single-blind study was to assess efficacy of the anti aging effect and the tolerance of Redermic alone compared to Rejuva-A™ (0.025% tretinoin) alone or in combination with Rejuva-A™ (0.025% tretinoin).
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). Subjects were randomized (1:1:1) in three groups of forty (40), and were asked to apply study product to the face (except to eyelids, nostrils and other mucous membranes) for 24 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Redermic | Experimental | Cream was applied twice a day every day, morning and evening for 24 weeks. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Redermic | Other | Cosmetic cream formulation 609637 43. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Evaluation by a Panel of Blinded Dermatologists. | A blinded panel of two dermatologists had to identify independently which of the two photographs had an improvement or if there was no noticeable difference between them. The two photographs of each subject were randomized to keep the blind. When the Week 24 photograph was selected as the one showing an improvement, it was scored by the statistician as "improvement". When the Day 0 photograph was selected as the one showing an improvement, it was scored by the statistician as "worsening". When there was no noticeable difference between the photographs, it was scored as "stable". |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette, MD, FRCPC | Innovaderm Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovaderm Research Inc | Montreal | Quebec | H2K 4L5 | Canada |
Not provided
Subjects were recruited from September 2009 to January 2010 at a research clinic.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Redermic | Cream applied twice a day every day, morning and evening for 24 weeks. |
| FG001 | Rejuva-A | 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, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks. |
| FG002 | Combination of Redermic and Rejuva-A | 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, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Redermic | Cream applied twice a day every day, morning and evening for 24 weeks. |
| BG001 | Rejuva-A | 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, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Posted | Mean | Standard Deviation | Units on a scale | 12, 24 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Redermic | Cream applied twice a day every day, morning and evening for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annie Levesque | Innovaderm Research Inc | 514-521-4285 | 222 | alevesque@innovaderm.ca |
Not provided
| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tretinoin (Rejuva-A) | Drug | Tretinoin 0.025% cream. |
|
|
| 24 weeks |
| Trans-epidermal Water Loss (TEWL). | Trans Epidermal Water Loss (TEWL) was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a TEWL probe. Measurements were performed with the subject lying down on the back in a room with controlled temperature (20°C +/-2) and relative humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject was transferred into this room. The measurements were performed on the cheek. Care was taken to use the same cheek for each subject throughout the study. | 12, 24 weeks |
| Skin Hydration (Conductance) | Skin hydration was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin hydration probe. Measurements were performed in a room with controlled temperature (20°C +/-2) and humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject had been transferred into this room. Care was taken to use the same cheek for each subject throughout the study. Higher values indicate greater hydration. | 12, 24 weeks |
| Skin Elasticity. | Skin elasticity was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin elasticity probe. Pressure required to raise the skin 1mm was recorded. Measurements were performed on the upper cheeks and care was taken to use the same location for all measurements. Final measurements were the average of left and right cheeks. When the product is a moisturizer, lower pressures are indicative of efficacy. | 12, 24 weeks |
| Area Ratio - Analysis of Skin Replicas of Crow's Feet. | An illuminator is used to cross illuminate the specimen (silicone mold replicas) perpendicular to the major lines which accentuate the surface details. The resulting image which consists of a series of shadows that directly correspond to the pattern of wrinkles is digitized for analysis. One can measure changes in skin surface topography by selecting an area range (shadow size) that allows one to directly determine the projected area of the shadowed region associated with the wrinkles and major lines. The Area Ratio is the area of the shadows. The higher the ratio, the greater the wrinkling. | 24 weeks |
| Clinical Skin Evaluation. | A clinical skin evaluation of the face was performed by a dermatologist using 8 scales (skin hydration, radiance, roughness, spots, laxity, skin tone homogeneity, softness, relief (variations in depth)). The individual scores were totalled (worst = 0, best = 47) and the total score was used for analyses. | 12, 24 weeks |
| Sensitivity of the Face Evaluated by Subject. | Sensitivity of the entire face evaluated by the subject was performed using 4 different 10 cm visual analog scales (pruritus, tingling, burning, tightness). Each score was analysed separately. Each score is from 0 = absent to 10 important. | 12, 24 weeks |
| Facial Skin Self-evaluation. | A visual analog scale of 13 evaluations were performed by the subject. Scale is from 1 - 10 for each evaluation individually evaluated. 0 = absent, 10 = important. | 12, 24 weeks |
| Tolerance Evaluated by Investigator. | Tolerance was studied by evaluating scaling, dryness, erythema and burning/itching sensation on a 5-point scale. Scaling, Dryness and Erythema Evaluations - None (0) - Very Severe = (4) Burning and Itching Evaluation Scale
| 12, 24 weeks |
| BG002 | Combination of Redermic and Rejuva-A | 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, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Skin aging measured with 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). | Mean | Standard Deviation | Units on a Scale |
|
| Transepidermal water loss (TEWL) | Trans Epidermal Water Loss (TEWL) was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a TEWL probe. Measurements were performed with the subject lying down on the back in a room with controlled temperature (20°C +/-2) and relative humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject was transferred into this room. The measurements were performed on the cheek. Care was taken to use the same cheek for each subject throughout the study. | Mean | Standard Deviation | g / m² / h |
|
| Skin hydration (conductance) | Skin hydration was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin hydration probe. Measurements were performed in a room with controlled temperature (20°C +/-2) and humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject had been transferred into this room. Care was taken to use the same cheek for each subject throughout the study. Higher values indicate greater hydration. | Mean | Standard Deviation | µsiemens (µmho) |
|
| Skin elasticity | Skin elasticity was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin elasticity probe. Pressure required to raise the skin 1mm was recorded. Measurements were performed on the upper cheeks and care was taken to use the same location for all measurements. Final measurements were the average of left and right cheeks. When the product is a moisturizer, lower pressures are indicative of efficacy. | Mean | Standard Deviation | kilo Pascals |
|
| Crow's feet replicas - area ratio | An illuminator is used to cross illuminate the specimen (silicone mold replicas) perpendicular to the major lines which accentuate the surface details. The resulting image which consists of a series of shadows that directly correspond to the pattern of wrinkles is digitized for analysis. One can measure changes in skin surface topography by selecting an area range (shadow size) that allows one to directly determine the projected area of the shadowed region associated with the wrinkles and major lines. The Area Ratio is the area of the shadows. The higher the ratio, the greater the wrinkling. | Mean | Standard Deviation | mm² |
|
| Clinical skin evaluation | A clinical skin evaluation of the face was performed by a dermatologist using 8 scales (skin hydration, radiance, roughness, spots, laxity, skin tone homogeneity, softness, relief (variations in depth)). The individual scores were totalled (worst = 0, best = 47) and the total score was used for analyses. | Mean | Standard Deviation | Units on a scale |
|
| Sensitivity of the face evaluated by subject | Sensitivity of the entire face evaluated by the subject was performed using 4 different 10 cm visual analog scales (pruritus, tingling, burning, tightness). Each score was analysed separately. Each score is from 0 = absent to 10 important. | Mean | Standard Deviation | Units on a scale |
|
| Facial skin self-evaluation | A visual analog scale of 13 evaluations were performed by the subject. Scale is from 1 - 10 for each evaluation individually evaluated. 0 = absent, 10 = important | Mean | Standard Deviation | Units on a scale |
|
| Tolerance evaluated by investigator | Tolerance was studied by evaluating scaling, dryness, erythema and burning/itching sensation on a 5-point scale. Scaling, Dryness and Erythema Evaluations - None (0) - Very Severe = (4) Burning and Itching Evaluation Scale
| Mean | Standard Deviation | Units on a scale |
|
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, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks. |
| OG002 | Combination of Redermic and Rejuva-A | 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, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning. |
|
|
| Secondary | Photographic Evaluation by a Panel of Blinded Dermatologists. | A blinded panel of two dermatologists had to identify independently which of the two photographs had an improvement or if there was no noticeable difference between them. The two photographs of each subject were randomized to keep the blind. When the Week 24 photograph was selected as the one showing an improvement, it was scored by the statistician as "improvement". When the Day 0 photograph was selected as the one showing an improvement, it was scored by the statistician as "worsening". When there was no noticeable difference between the photographs, it was scored as "stable". | Analysis was intent to treat (ITT). Photographs taken at early termination visit were not available for every early termination subject as some subjects refused to have their photographs taken. Thus, early termination and lost to follow-up subjects were excluded from this analysis. The total number of subjects included in the ITT analysis was 92. | Posted | Number | Participants | 24 weeks |
|
|
|
| Secondary | Trans-epidermal Water Loss (TEWL). | Trans Epidermal Water Loss (TEWL) was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a TEWL probe. Measurements were performed with the subject lying down on the back in a room with controlled temperature (20°C +/-2) and relative humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject was transferred into this room. The measurements were performed on the cheek. Care was taken to use the same cheek for each subject throughout the study. | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Posted | Mean | Standard Deviation | g / m² / h | 12, 24 weeks |
|
|
|
| Secondary | Skin Hydration (Conductance) | Skin hydration was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin hydration probe. Measurements were performed in a room with controlled temperature (20°C +/-2) and humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject had been transferred into this room. Care was taken to use the same cheek for each subject throughout the study. Higher values indicate greater hydration. | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Posted | Mean | Standard Deviation | µsiemens (µmho) | 12, 24 weeks |
|
|
|
| Secondary | Skin Elasticity. | Skin elasticity was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin elasticity probe. Pressure required to raise the skin 1mm was recorded. Measurements were performed on the upper cheeks and care was taken to use the same location for all measurements. Final measurements were the average of left and right cheeks. When the product is a moisturizer, lower pressures are indicative of efficacy. | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Posted | Mean | Standard Deviation | kilo Pascals | 12, 24 weeks |
|
|
|
| Secondary | Area Ratio - Analysis of Skin Replicas of Crow's Feet. | An illuminator is used to cross illuminate the specimen (silicone mold replicas) perpendicular to the major lines which accentuate the surface details. The resulting image which consists of a series of shadows that directly correspond to the pattern of wrinkles is digitized for analysis. One can measure changes in skin surface topography by selecting an area range (shadow size) that allows one to directly determine the projected area of the shadowed region associated with the wrinkles and major lines. The Area Ratio is the area of the shadows. The higher the ratio, the greater the wrinkling. | Only the per protocol (PP) population was considered for this analysis. Early termination and lost subjects were excluded from this analysis. Furthermore, some replicas of subjects who completed the study could not be analyzed with precision and were consequently excluded from the analysis by the laboratory. | Posted | Mean | Standard Deviation | mm² | 24 weeks |
|
|
|
| Secondary | Clinical Skin Evaluation. | A clinical skin evaluation of the face was performed by a dermatologist using 8 scales (skin hydration, radiance, roughness, spots, laxity, skin tone homogeneity, softness, relief (variations in depth)). The individual scores were totalled (worst = 0, best = 47) and the total score was used for analyses. | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Posted | Mean | Standard Deviation | Units on a scale | 12, 24 weeks |
|
|
|
| Secondary | Sensitivity of the Face Evaluated by Subject. | Sensitivity of the entire face evaluated by the subject was performed using 4 different 10 cm visual analog scales (pruritus, tingling, burning, tightness). Each score was analysed separately. Each score is from 0 = absent to 10 important. | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Posted | Mean | Standard Deviation | Units on a scale | 12, 24 weeks |
|
|
|
| Secondary | Facial Skin Self-evaluation. | A visual analog scale of 13 evaluations were performed by the subject. Scale is from 1 - 10 for each evaluation individually evaluated. 0 = absent, 10 = important. | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Posted | Mean | Standard Deviation | Units on a scale | 12, 24 weeks |
|
|
|
| Secondary | Tolerance Evaluated by Investigator. | Tolerance was studied by evaluating scaling, dryness, erythema and burning/itching sensation on a 5-point scale. Scaling, Dryness and Erythema Evaluations - None (0) - Very Severe = (4) Burning and Itching Evaluation Scale
| Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Posted | Mean | Standard Deviation | Units on a scale | 12, 24 weeks |
|
|
|
| 1 |
| 40 |
| 3 |
| 40 |
| EG001 | Rejuva-A | 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, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks. | 0 | 40 | 10 | 40 |
| EG002 | Combination of Redermic and Rejuva-A | 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, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning. | 0 | 40 | 6 | 40 |
| Common Cold | Infections and infestations | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| Stable |
|
| Improvement |
|
|
|
|
|
|
| Tingling sensation Week 12 |
|
| Tingling sensation Week 24 |
|
| Burning sensation Week 12 |
|
| Burning sensation Week 24 |
|
| Tightness sensatioin Week 12 |
|
| Tightness sensation Week 24 |
|
|
| Firmness Week 12 |
|
| Firmness Week 24 |
|
| Radiance Week 12 |
|
| Radiance Week 24 |
|
| Softness Week 12 |
|
| Softness Week 24 |
|
| Comfort Week 12 |
|
| Comfort Week 24 |
|
| Smoothness Week 12 |
|
| Smoothness Week 24 |
|
| Fine lines Week 12 |
|
| Fine lines Week 24 |
|
| Wrinkles Week 12 |
|
| Wrinkles Week 24 |
|
| Spots Week 12 |
|
| Spots Week 24 |
|
| Roughness Week 12 |
|
| Roughness Week 24 |
|
| Imperfections Week 12 |
|
| Imperfections Week 24 |
|
| Dryness Week 12 |
|
| Dryness Week 24 |
|
| Redness Week 12 |
|
| Redness Week 24 |
|
|
| Dryness Week 12 |
|
| Dryness Week 24 |
|
| Erythema Week 12 |
|
| Erythema Week 24 |
|
| Burning and itching Week 12 |
|
| Burning and itching Week 24 |
|