NCT00272610

Brief Summary

The objectives of this study are to evaluate the safety and efficacy of 0.5% retinol (Vitamin A) versus it's vehicle cream in the treatment and prevention of skin aging and Bateman's Purpura (bruising).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2000

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
Last Updated

June 24, 2015

Status Verified

September 1, 2006

First QC Date

January 3, 2006

Last Update Submit

June 23, 2015

Conditions

Skin AgingPurpura

Keywords

Skin AgingBateman's Purpura

Outcome Measures

Primary Outcomes (4)

  • Surface Roughness

  • Fine wrinkles

  • Hyperpigmentation

  • Purpura

Secondary Outcomes (3)

  • Collagen content of skin biopsies

  • Glycosaminoglycan expression

  • CRABP-II expression

Interventions

0.4% Retinol CreamDRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male and female
  • years of age or older
  • history of Bateman's purpura on arms
  • Relatively good general health and able to perform daily tasks

You may not qualify if:

  • Sensitivity to any formulation ingredients
  • History of Cardiovascular disease with continuing deficits (example: partial paralysis)
  • Participated in any clinical trials within last 30 days
  • Topical steroids or other drugs two weeks prior to study entry (short-term application of topical antimicrobials is allowed)
  • Hormone replacement therapy within last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Kafi R, Kwak HS, Schumacher WE, Cho S, Hanft VN, Hamilton TA, King AL, Neal JD, Varani J, Fisher GJ, Voorhees JJ, Kang S. Improvement of naturally aged skin with vitamin A (retinol). Arch Dermatol. 2007 May;143(5):606-12. doi: 10.1001/archderm.143.5.606.

    PMID: 17515510DERIVED

MeSH Terms

Conditions

Purpura

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • John J Voorhees, MD

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 6, 2006

Study Start

September 1, 2000

Study Completion

February 1, 2002

Last Updated

June 24, 2015

Record last verified: 2006-09

Locations

US(1)