ST266 in UV-induced Inflammation

NCT02389777 | Completed Phase 2

• 1 other identifier: ST-06-14
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase II clinical study will include fifteen healthy light skinned adult volunteers. At screening subjects will be given a sunburn test. This procedure involves exposing eight 1 square cm areas of skin over increasing doses of simulated solar radiation (SSR). SSR is delivered by a 1,000-Watt xenon arc lamp, which emits ultraviolet wavelengths from 290-400 nm, closely resembling natural sunlight. The Minimal Erythema Dose (MED) will be determined approximately 24 hours after initial exposure by using a chromometer. The MED is calculated by linear regression. Each test site is a one inch square area on the buttock or lower back. Sites 1, 2, 3, 4, 5 will be irradiated with 2 MED of SSR. Site 1 will not receive any ST266 treatment. Sites 2 and 3 will be treated with ST266 immediately after irradiation. 8-12 hours later or at bedtime, Sites 2,3,4,5 with ST266 at home. ST266 will also be applied 24 hours after SSR. Between 24-36 hours after SSR, subject returns to the Skin Study Center for Minolta chromometer assessment of erythema at all test sites, as well as for high resolution digital photography (Canfield). These assessments will be repeated at 48 hours and 72 hours post SSR. Data will be graphed to quantify rate of erythema resolution. Punch biopsies will be obtained at Site 1 (control) and Site 2 (SSR + immediate ST266 Rx). If a difference in erythema is observed between Site 1 and Site 4, a biopsy will also be obtained from Site 4 (SSR + delayed ST266 Rx). Biopsy samples will be tested using Reverse Transcriptase -Polymerase Chain Reaction (RT-PCR) and/or immunohistochemistry for markers of UV inflammation such as Interleukin (IL)-6, Tumor Necrosis Factor (TNF) -alpha, etc. Subjects will continue to apply the ST266 twice daily on Sites 3 and 5 until study visit 5. An additional normal control skin biopsy may be performed in a subset of volunteers (4-5) to serve as reference control for the tissue analysis.

Conditions

Skin Burns

Outcome Measures

Primary Outcomes (1)

• Erythema resolution

  Erythema measured by Chromometer

  3 days

Secondary Outcomes (1)

• Skin punch biopsy

  Baseline and end of study period (day 3)

Study Arms (3)

Control UV burn

NO INTERVENTION

No treatment of the UV Light burn will be given

ST266 treated UV burn immediately

ACTIVE COMPARATOR

ST266 will be applied topically immediately by spray to the UV light burn wound

Biological: ST266 immediate

ST266 treated UV burn delayed

ACTIVE COMPARATOR

ST266 will be applied topically by spray to the UV light burn beginning 6 - 12 hours after the burn

Biological: ST266 delayed

Interventions

ST266 immediate BIOLOGICAL

ST266 will be applied immediately to the UV light burn wound topically by spray twice per day

ST266 treated UV burn immediately

ST266 delayed BIOLOGICAL

ST266 will be applied to the UV light burn topically by spray twice per day beginning 6-12 hours after the burn

ST266 treated UV burn delayed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 years or older
• Fitzpatrick Skin Type I-III
• In good general Adults health

You may not qualify if:

• Known history of photodermatosis or photosensitivity disorder such as systemic lupus or porphyria
• Tanning bed exposure within the last 4 weeks
• Current intake of known strong photosensitizers such as doxycycline/tetracycline family of antibiotics and thiazide diuretics
• Current intake of immunosuppressive drugs such as oral steroids.
• Cancer or known history of cancer within the last 5 years.

Sponsors & Collaborators

• Noveome Biotherapeutics, formerly Stemnion: lead

MeSH Terms

Conditions

Paresthesia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David L Steed, MD

  Noveome Biotherapeutics, formerly Stemnion

  STUDY DIRECTOR

• Elma D Baron, MD

  Cae Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share