Actinic KeratosisPhase 2NCT02126670
ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
A Phase 2 study testing ACT01, Comp01 and Comp02 in people with Actinic Keratosis, run by Promius Pharma, LLC at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- ACT01, Comp01 and Comp02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2014to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dermatology Consulting Services; Zoe Diana Draelos, MD
High Point, North Carolina, 27262
Dermatology Specialists Research, LLC
Louisville, Kentucky, 40202
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Therapeutics Clinical Research
San Diego, California, 92123
About this study
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.
- Conditions
- Actinic Keratosis
- Being tested
- ACT01, Comp01, Comp02, Comp03, Comp04
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT01Drug
Comp01Drug
Comp02Drug
Comp03Drug
Comp04Drug
| Study group | Role | What they receive |
|---|---|---|
| ACT01 plus Comp01 | Placebo comparator | ACT01 Cream in combination with Comp01 Cream, once daily, 29 days Receives: Drug: ACT01; Drug: Comp01 |
| ACT01 plus Comp02 | Active comparator | ACT01 Cream in combination with Comp02 Cream, once daily, 29 days Receives: Drug: ACT01; Drug: Comp02 |
| ACT01 plus Comp03 | Active comparator | ACT01 Cream in combination with Comp03 Cream, once daily, 29 days Receives: Drug: ACT01; Drug: Comp03 |
| ACT01 plus Comp04 | Other | ACT01 Cream in combination with Comp04 Cream, once daily, 29 days Receives: Drug: ACT01; Drug: Comp04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success at End of Study Visit
Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions
Measured: up to Day 57
Secondary outcomes (1)
Irritation Score
Percentage of participants with moderate or severe overall irritation at end of treatment.
Measured: up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promius Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126670
- Sponsor's protocol ID
- NP1401
- Status last verified
- Jan 2016
- First submitted
- 25 Apr 2014
- Last updated
- 22 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT02126670
- Acronym / sponsor ID
- NP1401
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Promius Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Posted 22 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ACT01 plus Comp01 | Placebo comparator | Drug: ACT01, Drug: Comp01ACT01 Cream in combination with Comp01 Cream, once daily, 29 days |
| ACT01 plus Comp02 | Active comparator | Drug: ACT01, Drug: Comp02ACT01 Cream in combination with Comp02 Cream, once daily, 29 days |
| ACT01 plus Comp03 | Active comparator | Drug: ACT01, Drug: Comp03ACT01 Cream in combination with Comp03 Cream, once daily, 29 days |
| ACT01 plus Comp04 | Other | Drug: ACT01, Drug: Comp04ACT01 Cream in combination with Comp04 Cream, once daily, 29 days |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT01 | Drug | ACT01 plus Comp01, ACT01 plus Comp02, ACT01 plus Comp03, ACT01 plus Comp04 |
| Comp01 | Drug | ACT01 plus Comp01 |
| Comp02 | Drug | ACT01 plus Comp02 |
| Comp03 | Drug | ACT01 plus Comp03 |
| Comp04 | Drug | ACT01 plus Comp04 |
Primary outcome
Treatment Success at End of Study Visit
Time frame: up to Day 57
Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions
1 secondary outcome
Irritation Score
Time frame: up to Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACT01, Comp01 and Comp02 in people with Actinic Keratosis, run by Promius Pharma, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success at End of Study Visit (time frame: up to Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.