NCT01106807

Brief Summary

The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

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

April 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 18, 2021

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

April 19, 2010

Last Update Submit

February 16, 2021

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

  • Total acne lesion count

    change in total number of acne lesion count from baseline to end of treatment

    6 weeks

  • Percent change of acne lesion count

    Percent change of acne lesion count from baseline to end of treatment

    6 weeks

Secondary Outcomes (4)

  • Lesion counts- Inflammatory

    6 weeks

  • Lesion count- non-inflammatory

    6 weeks

  • Lesion counts- Inflammatory

    6 weeks

  • Lesion count- non-inflammatory

    6 weeks

Study Arms (3)

CD07223 1.5% gel

EXPERIMENTAL

500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face

Drug: Epiduo vehicle gelDrug: CD07223

CD07223 0.5% gel

EXPERIMENTAL

500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face

Drug: Epiduo vehicle gelDrug: CD07223

Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

ACTIVE COMPARATOR

500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces

Drug: Epiduo vehicle gelDrug: Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

Interventions

Epiduo vehicle gelDRUG

500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

CD07223 0.5% gelCD07223 1.5% gelEpiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
CD07223DRUG

500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks

CD07223 1.5% gel
Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gelDRUG

500 microliters Epiduo Gel on one of the half-face for the morning dose

Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • subject has a clinical diagnosis of acne vulgaris with facial involvement
  • the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

You may not qualify if:

  • subject has a severe acne form or secondary acne form
  • the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
  • the subject has a known allergy or sensitivity to any of the components of the study products
  • subject is not willing to respect wash-out periods for topical and/or systemic treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Burke Pharmaceuticals

Hot Springs, Arkansas, United States

Location

Dermatology Specialist PSC

Louisville, Kentucky, 40202, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

TKL Research

Rochelle Park, New Jersey, 07662, United States

Location

Piedmont Medical Research

Winston-Salem, North Carolina, 27103, United States

Location

Cetero

Fargo, North Dakota, 58104, United States

Location

Derm Research, Inc

Austin, Texas, 78759, United States

Location

J & S Studies

Bryan, Texas, 77845, United States

Location

Education and Research Foundation, Inc

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene, Benzoyl Peroxide Drug CombinationAdapaleneBenzoyl PeroxideGels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsColloidsComplex MixturesDosage Forms

Study Officials

  • Michael Graeber, MD

    Galderma R&D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 20, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 18, 2021

Record last verified: 2012-04

Locations

US(9)