NCT01490736

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2011

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

December 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

December 7, 2011

Last Update Submit

July 16, 2021

Conditions

Acne

Keywords

AcneSebum gland disease

Outcome Measures

Primary Outcomes (1)

  • Change in sebum excretion rate

    Baseline to Day 14

Secondary Outcomes (2)

  • Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)

    Baseline to Day 14

  • Change in acne lesion count

    Baseline to Day 14

Study Arms (1)

LTS/Vehicle

EXPERIMENTAL

Within subject control study

Drug: Lemuteporfin

Interventions

LemuteporfinDRUG

lemuteporfin topical solution, 1%

LTS/Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovaderm Research, Inc

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

lemuteporfin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Robert Bissonnette, MD

    Innovaderm Research Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2011

First Posted

December 13, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

CA(1)