NCT00647556

Brief Summary

The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

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

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 24, 2011

Completed
Last Updated

August 1, 2022

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

March 26, 2008

Results QC Date

January 28, 2011

Last Update Submit

July 28, 2022

Conditions

Photoaging

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24

    Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.

    baseline to week 24

Secondary Outcomes (4)

  • Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24

    baseline, week 12 and week 24

  • Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.

    baseline to week 12

  • Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24

    week 12 and week 24

  • Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24

    week 12 and week 24

Study Arms (2)

adapalene

ACTIVE COMPARATOR

adapalene

Drug: adapalene gel, 0.3%

tretinoin

ACTIVE COMPARATOR

Tretinoin

Drug: tretinoin 0.05% emollient cream

Interventions

adapalene gel, 0.3%DRUG

applied topically once daily in the evening

Also known as: Differin® 0.3% Gel
adapalene
tretinoin 0.05% emollient creamDRUG

applied topically once daily in the evening

Also known as: tretinoin emollient cream 0.05%
tretinoin

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female aged 40 years of age and older with Fitzpatrick skin types I through III
  • Clinically moderate to severe photodamage

You may not qualify if:

  • Subjects with history of laser resurfacing, dermabrasion, medium or deep chemical peel of the face
  • Subjects with diagnosis of skin cancer within 3 months of study entry
  • Subjects who have had superficial chemical peels, exfoliation or microdermabrasion of the face within 3 months of study entry
  • Subjects who have had botulinum toxin for facial rejuvenation within 6 months of study entry and are unwilling to refrain from botulinum toxin treatments during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

AdapaleneGelsTretinoin

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsColloidsComplex MixturesDosage FormsPharmaceutical PreparationsVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Results Point of Contact

Title
Ronald W. Gottschalk, MD / Medical Director
Organization
Galderma Laboratories, L.P.
ron.gottschalk@galderma.com
817-961-5358

Study Officials

  • Ronald W Gottschalk, MD

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 1, 2022

Results First Posted

February 24, 2011

Record last verified: 2012-09

Locations

US(1)