Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne |
Drug: Lemuteporfin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne |
- Change in sebum excretion rate [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 125 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LTS/Vehicle
Within subject control study
|
Drug: Lemuteporfin
lemuteporfin topical solution, 1%
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dermira, Inc. |
| ClinicalTrials.gov Identifier: | NCT01490736 History of Changes |
| Other Study ID Numbers: | LTS ACN-05 |
| Study First Received: | December 7, 2011 |
| Last Updated: | May 9, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Dermira, Inc.:
|
Acne Sebum gland disease |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
ClinicalTrials.gov processed this record on May 16, 2013