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Retinol on Human Skin Aging in East Asian Descent

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ClinicalTrials.gov Identifier: NCT02906566
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Anne Chang, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Intrinsic Aging of Skin
Interventions Drug: Retinol
Drug: Placebo
Enrollment 110
Recruitment Details  
Pre-assignment Details 110 participants were consented; 34 participants were assigned to a study arm.
Arm/Group Title Older Group Ages 55-75 Young Group Ages 18-25
Hide Arm/Group Description Participants received retinol lotion on one arm and placebo to match on the other arm. Participants in the group will give a tissue sample from one arm only for comparison.
Period Title: Overall Study
Number of participants Number of units (Arms) Number of participants Number of units (Arms)
Started 24 48 10 10
Completed 21 42 10 10
Not Completed 3 6 0 0
Arm/Group Title Older Group Ages 55-75 Young Group Ages 18-25 Total
Hide Arm/Group Description Participants received retinol lotion on one arm and placebo to match on the other arm. Participants in the group will give a tissue sample from one arm only for comparison. Total of all reporting groups
Overall Number of Baseline Participants 24 10 34
Hide Baseline Analysis Population Description
Participants who were assigned to a treatment arm were included in the analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 10 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  45.8%
10
 100.0%
21
  61.8%
>=65 years
13
  54.2%
0
   0.0%
13
  38.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 10 participants 34 participants
66  (4.7) 21.7  (3.1) 51.7  (21.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 10 participants 34 participants
Female
24
 100.0%
10
 100.0%
34
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 10 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
24
 100.0%
10
 100.0%
34
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants 10 participants 34 participants
24
 100.0%
10
 100.0%
34
 100.0%
1.Primary Outcome
Title Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo)
Hide Description Differences in transcript levels are reported as the number that were upregulated or downregulated in the participant's retinol-treated arm versus their placebo-treated arm.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis.
Arm/Group Title Older Group Ages 55-75
Hide Arm/Group Description:
Participants received retinol lotion on one arm and placebo to match on the other arm.
Overall Number of Participants Analyzed 24
Overall Number of Units Analyzed
Type of Units Analyzed: Genes
56615
Measure Type: Number
Unit of Measure: genes
Upregulated 23
Downregulated 21
2.Primary Outcome
Title Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline)
Hide Description Differences in transcript levels are reported as the number of genes that were upregulated or downregulated in the Younger Group participant tissue samples, as compared to a baseline provided by tissue samples collected from the Older Group (prior to their treatment).
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Only the participants in "Younger Group (ages 18-25)" are included in the analysis, since a comparison of the baseline data for the "Older Group (ages 55-75)" against itself is not clinically meaningful.
Arm/Group Title Young Group Ages 18-25
Hide Arm/Group Description:
Participants in the group will give a tissue sample from one arm only for comparison.
Overall Number of Participants Analyzed 10
Overall Number of Units Analyzed
Type of Units Analyzed: Genes
56615
Measure Type: Number
Unit of Measure: genes
Downregulated 775
Upregulated 587
3.Secondary Outcome
Title Transepidermal Water Loss
Hide Description Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis.
Arm/Group Title Retinol Treated Arm Placebo Treated Arm
Hide Arm/Group Description:
Participants in the older group (ages 55-75), retinol arm.
Participants in the older group (ages 55-75), placebo arm.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: g/h/m^2
Baseline 17.1  (10.2) 16.2  (11.7)
Week 12 9.4  (6.7) 10.2  (6.1)
4.Secondary Outcome
Title Severity of Arm Skin Wrinkling
Hide Description Wrinkling was assessed by the investigator using a 10-point Likert scale (range 0 to 9, lower scores correspond to less wrinkling).
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis.
Arm/Group Title Retinol Treated Arm Placebo Treated Arm
Hide Arm/Group Description:
Participants in the older group (ages 55-75), retinol arm.
Participants in the older group (ages 55-75), placebo arm.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.15  (1.96) 5.5  (1.59)
Week 12 4.85  (1.79) 5.175  (1.28)
5.Secondary Outcome
Title Elasticity on Arm Skin
Hide Description Elasticity was assessed using cutometry (R2 curve) as millimeters per second
Time Frame Baseline; week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis.
Arm/Group Title Retinol Treated Arm Placebo Treated Arm
Hide Arm/Group Description:
Participants in the older group (ages 55-75), retinol arm.
Participants in the older group (ages 55-75), placebo arm.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: millimeters per second
Baseline 0.8623  (0.0791) 0.8753  (0.0464)
Week 12 0.8587  (0.0655) 0.8576  (0.0684)
6.Secondary Outcome
Title Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events
Hide Description Skin and subcutaneous adverse events were assessed for this outcome and documented and scored according to CTCAE version 4.03.
Time Frame Baseline through week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis.
Arm/Group Title Retinol Treated Arm Placebo Treated Arm
Hide Arm/Group Description:
Participants in the older group (ages 55-75), retinol arm.
Participants in the older group (ages 55-75), placebo arm.
Overall Number of Participants Analyzed 21 21
Measure Type: Count of Participants
Unit of Measure: Participants
Dermatitis (Grade 1)
1
   4.8%
1
   4.8%
Tingling sensation after application (Grade 1)
0
   0.0%
1
   4.8%
Time Frame Up to 12 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Older Group Ages 55-75 Young Group Ages 18-25
Hide Arm/Group Description Participants received retinol lotion on one arm and placebo to match on the other arm. Participants in the group will give a tissue sample from one arm only for comparison.
All-Cause Mortality
Older Group Ages 55-75 Young Group Ages 18-25
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Older Group Ages 55-75 Young Group Ages 18-25
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Older Group Ages 55-75 Young Group Ages 18-25
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/24 (16.67%)      0/10 (0.00%)    
Infections and infestations     
Upper respiratory infection   3/24 (12.50%)  4 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough   2/24 (8.33%)  2 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Anne L. Chang
Organization: Stanford University
Phone: 650-721-7195
Responsible Party: Anne Chang, Stanford University
ClinicalTrials.gov Identifier: NCT02906566     History of Changes
Other Study ID Numbers: 33762
First Submitted: February 26, 2016
First Posted: September 20, 2016
Results First Submitted: February 27, 2019
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019