Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01283464
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Photodamaged Skin; Wrinkles	Drug: Retinol; Drug: Tretinoin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-blinded, Single-center, Parallel-arm Comparison Study of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Retinol Retinol 1.0% cream	Drug: Retinol; 1.0% cream
Active Comparator: Tretinoin Tretinoin 0.02% cream	Drug: Tretinoin; 0.02% cream; Other Names: Retin-A Renova Atralin Aberela Airol Avita Stieva-A

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Dept. of Dermatology	Baltimore	Maryland	United States	21231

Sponsors and Collaborators

• Johns Hopkins University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• SkinMedica, Inc., company website

Publications

None provided.

• Responsible Party: Anna Chien, Assistant Professor, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01283464
• Other Study ID Numbers: SKM10-R-01
• First Posted: Jan 26, 2011
• Last Update Posted: Apr 4, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Anna Chien, Assistant Professor, Johns Hopkins University: Retinol; Tretinoin
• Additional relevant MeSH terms: Vitamin A; Tretinoin

Study Results

Participant Flow

Recruitment Details	Study period: January 2011-December 2011 Recruitment period: January 2011-June 2011 Setting: Academic referral center

Arm/Group Title	Retinol	Tretinoin
Arm/Group Description	Retinol 1.0% cream to entire face daily or as tolerated for 6 months	Tretinoin 0.02% cream to entire face daily or as tolerated for 6 months
Period Title: Overall Study
STARTED	12	12
COMPLETED	10	11
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Retinol	Tretinoin	Total
Arm/Group Description	Retinol 1.0% cream	Tretinoin 0.02% cream	Total of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 66.7%	9 75%	17 70.8%
>=65 years	4 33.3%	3 25%	7 29.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.8 (11.3)	62.7 (7.6)	61.8 (9.5)
Sex: Female, Male (Count of Participants)
Female	11 91.7%	11 91.7%	22 91.7%
Male	1 8.3%	1 8.3%	2 8.3%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Global Photodamage Severity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Retinol	Tretinoin
Arm/Group Description	Retinol 1.0% cream	Tretinoin 0.02% cream
Measure Participants	12	12
Mean (Standard Deviation) [units on a scale]	4.8 (1.687)	5.45 (1.572)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	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.
Arm/Group Title	Retinol		Tretinoin
Arm/Group Description	Retinol 1.0% cream		Tretinoin 0.02% cream
All Cause Mortality
	Retinol		Tretinoin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Retinol		Tretinoin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		2/12 (16.7%)
Gastrointestinal disorders
inpatient admission for near syncopal episode	0/12 (0%)	0	1/12 (8.3%)	1
Respiratory, thoracic and mediastinal disorders
inpatient admission for pneumonia	1/12 (8.3%)	1	0/12 (0%)	0
Surgical and medical procedures
inpatient admission for orthopedic surgery	0/12 (0%)	0	1/12 (8.3%)	1
Other (Not Including Serious) Adverse Events
	Retinol		Tretinoin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.