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A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

Sponsor
Dow Pharmaceutical Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01194375
Collaborator
(none)
180
Enrollment
20
Locations
3
Arms
15
Duration (Months)
9
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.

Condition or Disease Intervention/Treatment Phase
  • Drug: Low Strength IDP-107
  • Drug: High Strength IDP-107
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low Strength IDP-107

Drug: Low Strength IDP-107
Once a day for 16 weeks
Experimental: High Strength IDP-107

Drug: High Strength IDP-107
Once a day for 16 weeks
Placebo Comparator: Placebo

Drug: Placebo
Once a day for 16 weeks

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in the number of inflammatory lesions [Baseline and 22 weeks]

  2. Percent of patients who achieve success for the acne global severity score [Baseline and 22 weeks]

Secondary Outcome Measures

  1. Change from baseline in the number of non-inflammatory lesions [Baseline and 22 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Presence of acne vulgaris on the face and neck/trunk

  • Presence of inflammatory and non-inflammatory lesions on the face

Exclusion Criteria:

  • Presence of any skin condition on the face that could interfere with clinical evaluations

  • Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit

  • Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit

  • Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dermatology Specialists, Inc. Oceanside California United States 92056
2 Horizons Clinical Research Center, LLC Denver Colorado United States 80220
3 North Florida Dermatology Associates, PA Jacksonville Florida United States 32204
4 FXM Research Corp. Miami Florida United States 33175
5 Ameriderm Research Ormond Beach Florida United States 32174
6 Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana United States 46256
7 The Indiana Clinical Trials Center, PC Plainfield Indiana United States 46168
8 Pedia Research LLC Owensboro Kentucky United States 42301
9 ActivMed Practices and Research, Inc. Haverhill Massachusetts United States 01830
10 Hamzavi Dermatology Fort Gratiot Michigan United States 48059
11 Minnesota Clinical Study Center Fridley Minnesota United States 55432
12 Comprehensive Clinical Research Berlin New Jersey United States 08009
13 Oregon Dermatology and Research Center Portland Oregon United States 97210
14 DermResearch, Inc. Austin Texas United States 78759
15 Dermatology Research Center, Inc. Salt Lake City Utah United States 84124
16 South Valley Dermatology West Jordan Utah United States 84088
17 Premier Clinical Research Spokane Washington United States 99204
18 Ultranova Skincare Barrie Ontario Canada L4M 6L2
19 The Centre for Dermatology and Cosmetic Surgery Richmond Hill Ontario Canada L4B 1A5
20 K. Papp Clinical Research Waterloo Ontario Canada N2J 1C4

Sponsors and Collaborators

  • Dow Pharmaceutical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT01194375
Other Study ID Numbers:
  • DPSI-IDP-107-P2-02
First Posted:
Sep 3, 2010
Last Update Posted:
Jul 2, 2012
Last Verified:
Jun 1, 2012
Additional relevant MeSH terms:
Acne Vulgaris

Study Results

No Results Posted as of Jul 2, 2012