Photodamaged Skin, Wrinkles
Conditions
Keywords
Retinol, Tretinoin
Brief summary
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.
Interventions
DRUGRetinol
1.0% cream
DRUGTretinoin
0.02% cream
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 35 or over * Moderate to severe photodamage
Exclusion criteria
* History of facial cosmetic surgery, facial resurfacing procedures, deep peels, or facial fillers * History of keloids or hypertrophic scars * Use of oral steroids or oral retinoids (such as Accutane) in past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Photodamage Severity | Week 24 | 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. |
Countries
United States
Participant flow
Recruitment details
Study period: January 2011-December 2011 Recruitment period: January 2011-June 2011 Setting: Academic referral center
Participants by arm
| Arm | Count |
|---|---|
| Retinol Retinol 1.0% cream | 12 |
| Tretinoin Tretinoin 0.02% cream | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Tretinoin | Retinol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Continuous | 62.7 years STANDARD_DEVIATION 7.6 | 60.8 years STANDARD_DEVIATION 11.3 | 61.8 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 1 / 12 | 2 / 12 |
Outcome results
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.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retinol | Global Photodamage Severity | 4.8 units on a scale | Standard Deviation 1.687 |
| Tretinoin | Global Photodamage Severity | 5.45 units on a scale | Standard Deviation 1.572 |