Trial Outcomes & Findings for Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles (NCT NCT01283464)
NCT ID: NCT01283464
Last Updated: 2016-04-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Week 24
Results posted on
2016-04-04
Participant Flow
Study period: January 2011-December 2011 Recruitment period: January 2011-June 2011 Setting: Academic referral center
Participant milestones
| Measure |
Retinol
Retinol 1.0% cream to entire face daily or as tolerated for 6 months
|
Tretinoin
Tretinoin 0.02% cream to entire face daily or as tolerated for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Retinol
Retinol 1.0% cream to entire face daily or as tolerated for 6 months
|
Tretinoin
Tretinoin 0.02% cream to entire face daily or as tolerated for 6 months
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles
Baseline characteristics by cohort
| Measure |
Retinol
n=12 Participants
Retinol 1.0% cream
|
Tretinoin
n=12 Participants
Tretinoin 0.02% cream
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24A 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.
Outcome measures
| Measure |
Retinol
n=12 Participants
Retinol 1.0% cream
|
Tretinoin
n=12 Participants
Tretinoin 0.02% cream
|
|---|---|---|
|
Global Photodamage Severity
|
4.8 units on a scale
Standard Deviation 1.687
|
5.45 units on a scale
Standard Deviation 1.572
|
Adverse Events
Retinol
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Tretinoin
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Retinol
n=12 participants at risk
Retinol 1.0% cream
|
Tretinoin
n=12 participants at risk
Tretinoin 0.02% cream
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
inpatient admission for pneumonia
|
8.3%
1/12 • Number of events 1 • 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.
|
0.00%
0/12 • 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.
|
|
Surgical and medical procedures
inpatient admission for orthopedic surgery
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
inpatient admission for near syncopal episode
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place