Skin AgingNCT00974480
Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging
A study testing Redermic and Tretinoin (Rejuva-A) in people with Skin Aging, run by Cosmetique Active International at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Redermic and Tretinoin (Rejuva-A)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Subjects have had a filler injection (collagen, hyaluronic acid, etc..) on the face within 2 years of Day 0 or plan to receive this treatment during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Blind Study to Evaluate the Tolerance and Effectiveness of Redermic Versus Rejuva-A™ (0.025% Tretinoin) and Redermic in Combination With Rejuva-A™ (0.025% Tretinoin) Under Normal Conditions in Subjects With Signs of Aging
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).
Read the detailed description
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.
- Conditions
- Skin Aging
- Being tested
- Redermic, Tretinoin (Rejuva-A)
- Keywords
- Skin, Aging, Rejuva-a, Redermic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RedermicOther
Also called madescassoside, vitamin C
Cosmetic cream formulation 609637 43.
Tretinoin (Rejuva-A)Drug
Also called Rejuva-A
Tretinoin 0.025% cream.
| Study group | Role | What they receive |
|---|---|---|
| Redermic | Experimental | Cream was applied twice a day every day, morning and evening for 24 weeks. Receives: 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. Receives: 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. Receives: Other: Redermic; Drug: Tretinoin (Rejuva-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12, 24 weeks
Secondary outcomes (9)
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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
- 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
Measured: 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Responsible party
- Principal investigator, Robert BISSONNETTE, Cosmetique Active International
- Investigators
- Robert Bissonnette, MD, FRCPC, Principal investigator, Innovaderm Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974480
- Sponsor's protocol ID
- LRP09008
- Status last verified
- Sep 2011
- First submitted
- 24 Jul 2009
- Last updated
- 20 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind Study to Evaluate the Tolerance and Effectiveness of Redermic Versus Rejuva-A™ (0.025% Tretinoin) and Redermic in Combination With Rejuva-A™ (0.025% Tretinoin) Under Normal Conditions in Subjects With Signs of Aging
- ClinicalTrials.gov ID
- NCT00974480
- Acronym / sponsor ID
- LRP09008
- Conditions
- Skin Aging
- Keywords
- Skin, Aging, Rejuva-a, Redermic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Posted 15 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Redermic | Experimental | Other: RedermicCream was applied twice a day every day, morning and evening for 24 weeks. |
| Rejuva-A | Active comparator | Drug: Tretinoin (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, 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 | Other: Redermic, Drug: Tretinoin (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, 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. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RedermicAlso: madescassoside, vitamin CCosmetic cream formulation 609637 43. | Other | Combination of Redermic and Rejuva-A, Redermic |
| Tretinoin (Rejuva-A)Also: Rejuva-ATretinoin 0.025% cream. | Drug | Combination of Redermic and Rejuva-A, Rejuva-A |
Primary outcome
Skin Aging Measured With the Photonumeric Scale.
Time frame: 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).
9 secondary outcomes
Photographic Evaluation by a Panel of Blinded Dermatologists.
Time frame: 24 weeks
Trans-epidermal Water Loss (TEWL).
Time frame: 12, 24 weeks
Skin Hydration (Conductance)
Time frame: 12, 24 weeks
Skin Elasticity.
Time frame: 12, 24 weeks
Area Ratio - Analysis of Skin Replicas of Crow's Feet.
Time frame: 24 weeks
Clinical Skin Evaluation.
Time frame: 12, 24 weeks
Sensitivity of the Face Evaluated by Subject.
Time frame: 12, 24 weeks
Facial Skin Self-evaluation.
Time frame: 12, 24 weeks
Tolerance Evaluated by Investigator.
Time frame: 12, 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette, MD, FRCPC principal investigator
Innovaderm Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redermic and Tretinoin (Rejuva-A) in people with Skin Aging, run by Cosmetique Active International at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Aging Measured With the Photonumeric Scale. (time frame: 12, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.