Trial Outcomes & Findings for Retinol on Human Skin Aging in East Asian Descent (NCT NCT02906566)

NCT ID: NCT02906566

Last Updated: 2019-04-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 110 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2019-04-16

Participant Flow

110 participants were consented; 34 participants were assigned to a study arm.

Unit of analysis: Arms

Participant milestones

Measure	Older Group Ages 55-75 Participants received retinol lotion on one arm and placebo to match on the other arm.	Young Group Ages 18-25 Participants in the group will give a tissue sample from one arm only for comparison.
Overall Study STARTED	24 48	10 10
Overall Study COMPLETED	21 42	10 10
Overall Study NOT COMPLETED	3 6	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retinol on Human Skin Aging in East Asian Descent

Baseline characteristics by cohort

Measure	Older Group Ages 55-75 n=24 Participants Participants received retinol lotion on one arm and placebo to match on the other arm.	Young Group Ages 18-25 n=10 Participants Participants in the group will give a tissue sample from one arm only for comparison.	Total n=34 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	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 4.7 • n=5 Participants	21.7 years STANDARD_DEVIATION 3.1 • n=7 Participants	51.7 years STANDARD_DEVIATION 21.5 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	10 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	24 Participants n=5 Participants	10 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants	10 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: 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.

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.

Outcome measures

Measure	Older Group Ages 55-75 n=56615 genes Participants received retinol lotion on one arm and placebo to match on the other arm.	Placebo Treated Arm Participants in the older group (ages 55-75), placebo arm.
Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo) Upregulated	23 genes	—
Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo) Downregulated	21 genes	—

PRIMARY outcome

Timeframe: Week 1

Population: 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.

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).

Outcome measures

Measure	Older Group Ages 55-75 n=56615 genes Participants received retinol lotion on one arm and placebo to match on the other arm.	Placebo Treated Arm Participants in the older group (ages 55-75), placebo arm.
Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline) Downregulated	775 genes	—
Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline) Upregulated	587 genes	—

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: 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.

Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared.

Outcome measures

Measure	Older Group Ages 55-75 n=21 Participants Participants received retinol lotion on one arm and placebo to match on the other arm.	Placebo Treated Arm n=21 Participants Participants in the older group (ages 55-75), placebo arm.
Transepidermal Water Loss Week 12	9.4 g/h/m^2 Standard Deviation 6.7	10.2 g/h/m^2 Standard Deviation 6.1
Transepidermal Water Loss Baseline	17.1 g/h/m^2 Standard Deviation 10.2	16.2 g/h/m^2 Standard Deviation 11.7

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: 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.

Wrinkling was assessed by the investigator using a 10-point Likert scale (range 0 to 9, lower scores correspond to less wrinkling).

Outcome measures

Measure	Older Group Ages 55-75 n=20 Participants Participants received retinol lotion on one arm and placebo to match on the other arm.	Placebo Treated Arm n=20 Participants Participants in the older group (ages 55-75), placebo arm.
Severity of Arm Skin Wrinkling Baseline	5.15 units on a scale Standard Deviation 1.96	5.5 units on a scale Standard Deviation 1.59
Severity of Arm Skin Wrinkling Week 12	4.85 units on a scale Standard Deviation 1.79	5.175 units on a scale Standard Deviation 1.28

SECONDARY outcome

Timeframe: Baseline; week 12

Population: 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.

Elasticity was assessed using cutometry (R2 curve) as millimeters per second

Outcome measures

Measure	Older Group Ages 55-75 n=21 Participants Participants received retinol lotion on one arm and placebo to match on the other arm.	Placebo Treated Arm n=21 Participants Participants in the older group (ages 55-75), placebo arm.
Elasticity on Arm Skin Baseline	0.8623 millimeters per second Standard Deviation 0.0791	0.8753 millimeters per second Standard Deviation 0.0464
Elasticity on Arm Skin Week 12	0.8587 millimeters per second Standard Deviation 0.0655	0.8576 millimeters per second Standard Deviation 0.0684

SECONDARY outcome

Timeframe: Baseline through week 12

Population: 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.

Skin and subcutaneous adverse events were assessed for this outcome and documented and scored according to CTCAE version 4.03.

Outcome measures

Measure	Older Group Ages 55-75 n=21 Participants Participants received retinol lotion on one arm and placebo to match on the other arm.	Placebo Treated Arm n=21 Participants Participants in the older group (ages 55-75), placebo arm.
Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events Dermatitis (Grade 1)	1 Participants	1 Participants
Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events Tingling sensation after application (Grade 1)	0 Participants	1 Participants

Adverse Events

Older Group Ages 55-75

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Young Group Ages 18-25

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Older Group Ages 55-75 n=24 participants at risk Participants received retinol lotion on one arm and placebo to match on the other arm.	Young Group Ages 18-25 n=10 participants at risk Participants in the group will give a tissue sample from one arm only for comparison.
Infections and infestations Upper respiratory infection	12.5% 3/24 • Number of events 4 • Up to 12 weeks.	0.00% 0/10 • Up to 12 weeks.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 2/24 • Number of events 2 • Up to 12 weeks.	0.00% 0/10 • Up to 12 weeks.

Additional Information

Dr. Anne L. Chang

Stanford University

Phone: 650-721-7195

Email: alschang@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place