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

Acne Clinical Trial

Official title:

Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490736
• Other study ID #: LTS ACN-05
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• Lemuteporfin
lemuteporfin topical solution, 1%

Locations

Country	Name	City	State
Canada	Innovaderm Research, Inc	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Dermira, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sebum excretion rate		Baseline to Day 14
Secondary	Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)		Baseline to Day 14
Secondary	Change in acne lesion count		Baseline to Day 14