NCT02126670

Brief Summary

The purpose of this study is to determine whether or not ACT01 is effective and tolerable alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with facial and/or scalp keratosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

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

April 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 22, 2016

Completed
Last Updated

February 22, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

April 25, 2014

Results QC Date

November 24, 2015

Last Update Submit

January 25, 2016

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • Treatment Success at End of Study Visit

    Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions

    up to Day 57

Secondary Outcomes (1)

  • Irritation Score

    up to Day 57

Study Arms (4)

ACT01 plus Comp01

PLACEBO COMPARATOR

ACT01 Cream in combination with Comp01 Cream, once daily, 29 days

Drug: ACT01Drug: Comp01

ACT01 plus Comp02

ACTIVE COMPARATOR

ACT01 Cream in combination with Comp02 Cream, once daily, 29 days

Drug: ACT01Drug: Comp02

ACT01 plus Comp03

ACTIVE COMPARATOR

ACT01 Cream in combination with Comp03 Cream, once daily, 29 days

Drug: ACT01Drug: Comp03

ACT01 plus Comp04

OTHER

ACT01 Cream in combination with Comp04 Cream, once daily, 29 days

Drug: ACT01Drug: Comp04

Interventions

ACT01DRUG
ACT01 plus Comp01ACT01 plus Comp02ACT01 plus Comp03ACT01 plus Comp04
Comp01DRUG
ACT01 plus Comp01
Comp02DRUG
ACT01 plus Comp02
Comp03DRUG
ACT01 plus Comp03
Comp04DRUG
ACT01 plus Comp04

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter.
  • Age 30-85 years, inclusive.
  • Good general health as determined by investigator and supported by medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).

You may not qualify if:

  • Severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease.
  • Dermatologic conditions if present on the face such as acne, atopic dermatitis, seborrheic dermatitis, eczema, rosacea, or albinism.
  • Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy to the intended treatment area within 180 days prior to the Baseline Visit.
  • Use of sun lamps or sun tanning beds or booths during the 14 days prior to the Baseline Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Dermatology Specialists Research, LLC

Louisville, Kentucky, 40202, United States

Location

Dermatology Consulting Services; Zoe Diana Draelos, MD

High Point, North Carolina, 27262, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Director of Clinical Operations
Organization
Promius Pharma, LLC
kgulbronson@promiuspharma.com
609-282-1476

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 30, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 22, 2016

Results First Posted

February 22, 2016

Record last verified: 2016-01

Locations

US(4)