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The purpose of this study is to assess the comparative efficacy of retinol 1.0% and tretinoin 0.02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe photodamage. Our hypothesis is that both products will be of comparable benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retinol | Active Comparator | Retinol 1.0% cream |
|
| Tretinoin | Active Comparator | Tretinoin 0.02% cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retinol | Drug | 1.0% cream |
| |
| Tretinoin |
| Measure | Description | Time Frame |
|---|---|---|
| Global Photodamage Severity | A photonumeric scale for the assessment of cutaneous photodamage (CE Griffiths, et al). Five photographic standards (en face and 45 degrees oblique) illustrating increasing severity of photodamage (min=0, max=8) where 0=no damamge; 2=mild damage; 4=moderate damage; 6=moderate/severe damage; and grade 8=severe damage. | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Dept. of Dermatology | Baltimore | Maryland | 21231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35675051 | Derived | Chien AL, Kim DJ, Cheng N, Shin J, Leung SG, Nelson AM, Zang J, Suh H, Rainer B, Wallis L, Okoye GA, Loss M, Kang S. Biomarkers of Tretinoin Precursors and Tretinoin Efficacy in Patients With Moderate to Severe Facial Photodamage: A Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):879-886. doi: 10.1001/jamadermatol.2022.1891. |
| Label | URL |
|---|---|
| SkinMedica, Inc., company website | View source |
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Study period: January 2011-December 2011 Recruitment period: January 2011-June 2011 Setting: Academic referral center
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| ID | Title | Description |
|---|---|---|
| FG000 | Retinol | Retinol 1.0% cream to entire face daily or as tolerated for 6 months |
| FG001 | Tretinoin | Tretinoin 0.02% cream to entire face daily or as tolerated for 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Retinol | Retinol 1.0% cream |
| BG001 | Tretinoin | Tretinoin 0.02% cream |
| BG002 |
| 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 | Global Photodamage Severity | A photonumeric scale for the assessment of cutaneous photodamage (CE Griffiths, et al). Five photographic standards (en face and 45 degrees oblique) illustrating increasing severity of photodamage (min=0, max=8) where 0=no damamge; 2=mild damage; 4=moderate damage; 6=moderate/severe damage; and grade 8=severe damage. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
1 year
Other (non-serious) Adverse Events were collected/assessed in the entire study population, but none observed. A total of 3 serious adverse events occurred during the course of the trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retinol | Retinol 1.0% cream |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| inpatient admission for pneumonia | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna L. Chien | Johns Hopkins Dermatology | 4105027546 | ctrep@jhmi.edu |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Drug |
0.02% cream |
|
|
| Physician Decision |
|
| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| 1 |
| 12 |
| 0 |
| 12 |
| EG001 | Tretinoin | Tretinoin 0.02% cream | 2 | 12 | 0 | 12 |
| inpatient admission for orthopedic surgery | Surgical and medical procedures |
|
| inpatient admission for near syncopal episode | Gastrointestinal disorders |
|
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| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |