Trial · NCT00974480
Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging
NCT00974480, Not applicable, Completed, Cosmetique Active International; results first posted 2010-12-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging. Trials, record NCT00974480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00974480
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging
- NCT number
- NCT00974480
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 120 participants, actual
- Lead sponsor
- Cosmetique Active International
- Conditions
- Skin Aging
- Interventions
- Redermic, Tretinoin (Rejuva-A)
- First posted
- 2009-09-10
- Last updated
- 2011-09-20
- Results first posted
- 2010-12-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Skin Aging Measured With the Photonumeric Scale. | 12, 24 weeks | 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). |
| Secondary | Photographic Evaluation by a Panel of Blinded Dermatologists. | 24 weeks | 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". |
| Secondary | Trans-epidermal Water Loss (TEWL). | 12, 24 weeks | 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. |
| Secondary | Skin Hydration (Conductance) | 12, 24 weeks | 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. |
| Secondary | Skin Elasticity. | 12, 24 weeks | 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. |
| Secondary | Area Ratio - Analysis of Skin Replicas of Crow's Feet. | 24 weeks | 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. |
| Secondary | Clinical Skin Evaluation. | 12, 24 weeks | 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. |
| Secondary | Sensitivity of the Face Evaluated by Subject. | 12, 24 weeks | 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. |
| Secondary | Facial Skin Self-evaluation. | 12, 24 weeks | 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. |
| Secondary | Tolerance Evaluated by Investigator. | 12, 24 weeks | 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 * None (0) = Normal, no discomfort * Mild (1) = Slight discomfort that is not bothersome * Moderate (2) = Discomfort that is somewhat bothersome * Marked (3) = Discomfort that is bothersome and that occasionally interferes with normal daily activities * Severe (4) = Continuous discomfort that interferes with normal daily activities |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Skin Aging Measured With the Photonumeric Scale. | 12, 24 weeks | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Units on a scale | MEAN |
| SECONDARY | Photographic Evaluation by a Panel of Blinded Dermatologists. | 24 weeks | 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. | Participants | NUMBER |
| SECONDARY | Trans-epidermal Water Loss (TEWL). | 12, 24 weeks | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | g / m² / h | MEAN |
| SECONDARY | Skin Hydration (Conductance) | 12, 24 weeks | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | µsiemens (µmho) | MEAN |
| SECONDARY | Skin Elasticity. | 12, 24 weeks | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | kilo Pascals | MEAN |
| SECONDARY | Area Ratio - Analysis of Skin Replicas of Crow's Feet. | 24 weeks | 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. | mm² | MEAN |
| SECONDARY | Clinical Skin Evaluation. | 12, 24 weeks | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Units on a scale | MEAN |
| SECONDARY | Sensitivity of the Face Evaluated by Subject. | 12, 24 weeks | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Units on a scale | MEAN |
| SECONDARY | Facial Skin Self-evaluation. | 12, 24 weeks | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Units on a scale | MEAN |
| SECONDARY | Tolerance Evaluated by Investigator. | 12, 24 weeks | Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group177
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Skin Aging Measured With the Photonumeric Scale. | Redermic | Week 12 | 21.25 | Standard Deviation 6.60 | Units on a scale |
| Skin Aging Measured With the Photonumeric Scale. | Rejuva-A | Week 12 | 21.36 | Standard Deviation 5.93 | Units on a scale |
| Skin Aging Measured With the Photonumeric Scale. | Combination of Redermic and Rejuva-A | Week 12 | 21.21 | Standard Deviation 5.29 | Units on a scale |
| Skin Aging Measured With the Photonumeric Scale. | Redermic | Week 24 | 21.03 | Standard Deviation 6.81 | Units on a scale |
| Skin Aging Measured With the Photonumeric Scale. | Rejuva-A | Week 24 | 20.92 | Standard Deviation 5.75 | Units on a scale |
| Skin Aging Measured With the Photonumeric Scale. | Combination of Redermic and Rejuva-A | Week 24 | 21.31 | Standard Deviation 5.26 | Units on a scale |
| Photographic Evaluation by a Panel of Blinded Dermatologists. | Redermic - Assessor 1 | Worsening | 7 | Participants | |
| Photographic Evaluation by a Panel of Blinded Dermatologists. | Rejuva-A - Assessor 1 | Worsening | 4 | Participants | |
| Photographic Evaluation by a Panel of Blinded Dermatologists. | Combination of Redermic and Rejuva-A - Assessor 1 | Worsening | 5 | Participants | |
| Photographic Evaluation by a Panel of Blinded Dermatologists. | Redermic - Assessor 2 | Worsening | 5 | Participants |
1 to 10 of 177Source ClinicalTrials.gov
See all 177 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Redermic | 40 | |
| Overall Study | STARTED | Rejuva-A | 40 | |
| Overall Study | STARTED | Combination of Redermic and Rejuva-A | 40 | |
| Overall Study | COMPLETED | Redermic | 29 | |
| Overall Study | COMPLETED | Rejuva-A | 33 | |
| Overall Study | COMPLETED | Combination of Redermic and Rejuva-A | 30 | |
| Overall Study | NOT COMPLETED | Redermic | 11 | |
| Overall Study | NOT COMPLETED | Rejuva-A | 7 | |
| Overall Study | NOT COMPLETED | Combination of Redermic and Rejuva-A | 10 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis | Eye disorders | Redermic | 1 | 40 | 1 |
| other | Conjunctivitis | Eye disorders | Rejuva-A | 2 | 40 | 2 |
| other | Conjunctivitis | Eye disorders | Combination of Redermic and Rejuva-A | 0 | 40 | 0 |
| other | Common Cold | Infections and infestations | Redermic | 0 | 40 | 0 |
| other | Common Cold | Infections and infestations | Rejuva-A | 5 | 40 | 5 |
| other | Common Cold | Infections and infestations | Combination of Redermic and Rejuva-A | 2 | 40 | 2 |
| other | Dermatitis | Skin and subcutaneous tissue disorders | Redermic | 0 | 40 | 0 |
| other | Dermatitis | Skin and subcutaneous tissue disorders | Rejuva-A | 1 | 40 | 1 |
| other | Dermatitis | Skin and subcutaneous tissue disorders | Combination of Redermic and Rejuva-A | 4 | 40 | 4 |
| other | Influenza | Infections and infestations | Redermic | 0 | 40 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Redermic | ||
| Total, all-cause mortality | Rejuva-A | ||
| Total, all-cause mortality | Combination of Redermic and Rejuva-A | ||
| Total, other adverse events | Redermic | 3 | 40 |
| Total, other adverse events | Rejuva-A | 10 | 40 |
| Total, other adverse events | Combination of Redermic and Rejuva-A | 6 | 40 |
| Total, serious adverse events | Redermic | 1 | 40 |
| Total, serious adverse events | Rejuva-A | 0 | 40 |
| Total, serious adverse events | Combination of Redermic and Rejuva-A | 0 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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