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Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.
ClinicalTrials.gov Identifier:
NCT01490736
First received: December 7, 2011
Last updated: July 23, 2013
Last verified: July 2013

December 7, 2011
July 23, 2013
December 2011
March 2013   (final data collection date for primary outcome measure)
Change in sebum excretion rate [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01490736 on ClinicalTrials.gov Archive Site
  • Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase) [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
  • Change in acne lesion count [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne
Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne

The purpose of this study is to determine the safety of photodynamic therapy (PDT) with lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne.

This is a sequentially staged (Stage 1-4), proof of concept study assessing the safety of photodynamic therapy (PDT) and lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne. Approximately 12 subjects will be enrolled in Stage 1 in order to determine a maximum tolerated light dose following LTS application. Up to 90 subjects with mild acne will be enrolled in Stage 2 in order to assess the safety of PDT following a single LTS application. Up to 50 subjects will be enrolled in Stage 3 in order to assess the safety of PDT following repeat LTS applications. Up to 40 subjects will be enrolled into Stage 4 to assess multiple treatments of LTS-PDT.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acne
Drug: Lemuteporfin
lemuteporfin topical solution, 1%
Experimental: LTS/Vehicle
Within subject control study
Intervention: Drug: Lemuteporfin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
June 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stage 1 only: healthy subjects
  • Stage 1-4: male or female subjects age 18 years or older
  • Stage 2: subjects with sebum excretion rate of 4 or higher on forehead
  • Stage 2-4: subjects with at least 2 inflammatory acne lesions on the forehead
  • Stage 3-4: subjects with sebum excretion rate of 5 or higher on forehead

Exclusion Criteria:

  • Poor skin condition on back (Stage 1) or face (Stage 2 & 3)
  • Severe facial acne, acne fluminans/conglobata, or nodulocystic acne
  • Stage 2-4: previous use of Diane-35 within 6 months of Day 0, systemic acne treatment or systemic antibiotic treatment within 28 days of Day 0, topical acne treatment to the face within 14days of Day 0 or PDT to the face within 3 months of Day 0
  • Stage 2-4: previous treatment of isotretinoin or other oral retinoids
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01490736
LTS ACN-05
No
Dermira, Inc.
Dermira, Inc.
Not Provided
Principal Investigator: Robert Bissonnette, MD Innovaderm
Dermira, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP