Actinic KeratosisPhase 2NCT03210740
Safety and Efficacy Study of AM001 Cream in the Treatment of Actinic Keratosis
A Phase 2 study testing AM001 Cream, 7.5% in people with Actinic Keratosis, run by AmDerma at 1 site in United States.
Trial summary
To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of Actinic Keratosis (AK) Lesions Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- AM001 Cream, 7.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 24 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must provide written informed consent.
- Subject must be male or non-pregnant females of any race, and any skin type aged 18 to 80 years both inclusive.
- Subject has 4 to 8 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions, each at least 4 mm in diameter within a 25cm² contiguous treatment area on the face or the balding scalp.
- Subject is willing to avoid exposure to sunlight, use of tanning booths, sunlamps, or nonprescription UV (ultra-violate) light sources during the study period.ooths, sunlamps, or nonprescription UV (ultra-violate) light sources during the study period.
- If female subject of childbearing potential, the subject must have a negative urine pregnancy test at Visit 1/ Screening and must have been using an acceptable form of birth control for at least 2 months prior to Visit 1/ Screening and is willing to continue birth control during the study.
- Subject must be willing and able to understand and comply with the requirements of the study, apply the assigned investigational product as instructed, return for the required study visits, comply with therapy prohibitions.
- Subject must be in good health, as confirmed by medical history and physical exam, and free from any clinically significant disease/condition, other than actinic keratosis, that might interfere with the study evaluations.
Who cannot join
- Subject has very thick and/or hyperkeratotic actinic keratosis AK lesions in the treatment area.
- Subject has used topical treatment of actinic keratosis in the treatment area with 5-fluorouracil, imiquimod, diclofenac, corticosteroids or retinoids within 1 month prior to Visit 2/Baseline or during the study.
- Subject has used treatment with PDT (photodynamic therapy) or physical therapies (e. g. cryotherapy, curettage or surgical treatment) in the treatment area within 1 month prior to Visit 2/Baseline or during the study.
- Subject has used chemical peel, dermabrasion, laser abrasion, PUVA (prosalen plus ultraviolet A) therapy or UVB therapy within 6 months prior to Visit 2/Baseline or during the study.
- Subject has used immunomodulators or immunosuppressive therapies, interferon, oral corticosteroids, oral retinoids or cytotoxic drugs within 1 month prior to Visit 2/Baseline or during the study.
- Subject has untreated basal cell carcinoma, squamous cell carcinoma or melanoma in the treatment area.
Show all 14Show fewer
- Subject has suntan or tattoos that may interfere with the assessments in the treatment area.
- Subject has dermatological diseases in the treatment area that may interfere with the assessments, e.g. acute skin inflammation, atopic dermatitis, eczema, rosacea, psoriasis, seborrheic dermatitis, peri-oral dermatitis or hyperpigmentation.
- Subject who consumes excessive amount of alcohol, abuse or have any condition that in the investigator's opinion would compromise compliance, with this protocol.
- Subject has history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin.
- Female subject who is pregnant, nursing or planning a pregnancy within the study participation period
- Subject has symptoms of a clinically significant illness that may influence the outcome of the study in the 4 weeks prior to Visit 1/Screening.
- Subject has participated in another clinical trial involving investigational product or device in the 4 weeks prior to Visit 1/Screening.
- Subject has known allergic reactions to components of the investigational product.
Trial locations and contacts
1 site in 1 country.
United States1 site
AmDerma Pharmaceuticals, LLC
High Point, North Carolina, 27262
About this study
Official title: A Phase 2, Single-Center, Randomized, Double- Blind, Parallel-Group, Vehicle-Controlled Study Evaluating the Efficacy and Safety of AM001 Cream in the Treatment of Actinic Keratosis (AK) Lesions
To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of Actinic Keratosis (AK) Lesions
Read the detailed description
A Phase 2, Single-Center, Randomized, Double- Blind, Parallel-Group, Vehicle-Controlled Study Evaluating the Efficacy and Safety of AM001 Cream in the Treatment of Actinic Keratosis (AK) Lesions
- Conditions
- Actinic Keratosis
- Being tested
- AM001 Cream, 7.5%, Vehicle Cream
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM001 Cream, 7.5%Drug
Also called Potassium Dobesilate
Active Cream
Vehicle CreamDrug
Also called Placebo Cream
Placeo
| Study group | Role | What they receive |
|---|---|---|
| AM001 Cream, 7.5% | Experimental | A white to off-white Cream free from any foreign particles Receives: Drug: AM001 Cream, 7.5% |
| Vehicle Cream | Placebo comparator | A white to off-white Cream free from any foreign particles Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance of all lesions
(100 % of all AK lesions cleared) 8 weeks post treatment
Measured: 8 weeks post treatment
Secondary outcomes (3)
Complete clearance of all baseline lesions weeks of treatment
(100% of baseline AK lesions cleared) after 16 weeks of treatment
Measured: 16 weeks
Complete clearance of all lesions
(100% of baseline AK lesions cleared) after 12 weeks of treatment
Measured: 12 weeks
Complete clearance of all lesions
(100% of baseline AK lesions cleared) after 8 weeks of treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start6 Jun 2017
- Primary completion13 Feb 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmDerma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210740
- Sponsor's protocol ID
- AD-AM001-AK1
- Status last verified
- Sep 2018
- First submitted
- 5 Jul 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Center, Randomized, Double- Blind, Parallel-Group, Vehicle-Controlled Study Evaluating the Efficacy and Safety of AM001 Cream in the Treatment of Actinic Keratosis (AK) Lesions
- ClinicalTrials.gov ID
- NCT03210740
- Acronym / sponsor ID
- AD-AM001-AK1
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AmDermaIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of Actinic Keratosis (AK) Lesions
Detailed description
A Phase 2, Single-Center, Randomized, Double- Blind, Parallel-Group, Vehicle-Controlled Study Evaluating the Efficacy and Safety of AM001 Cream in the Treatment of Actinic Keratosis (AK) Lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AM001 Cream, 7.5% | Experimental | Drug: AM001 Cream, 7.5%A white to off-white Cream free from any foreign particles |
| Vehicle Cream | Placebo comparator | Drug: Vehicle CreamA white to off-white Cream free from any foreign particles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must provide written informed consent.
- Subject must be male or non-pregnant females of any race, and any skin type aged 18 to 80 years both inclusive.
- Subject has 4 to 8 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions, each at least 4 mm in diameter within a 25cm² contiguous treatment area on the face or the balding scalp.
- Subject is willing to avoid exposure to sunlight, use of tanning booths, sunlamps, or nonprescription UV (ultra-violate) light sources during the study period.ooths, sunlamps, or nonprescription UV (ultra-violate) light sources during the study period.
- If female subject of childbearing potential, the subject must have a negative urine pregnancy test at Visit 1/ Screening and must have been using an acceptable form of birth control for at least 2 months prior to Visit 1/ Screening and is willing to continue birth control during the study.
Key exclusion criteria (14 listed)
- Subject has very thick and/or hyperkeratotic actinic keratosis AK lesions in the treatment area.
- Subject has used topical treatment of actinic keratosis in the treatment area with 5-fluorouracil, imiquimod, diclofenac, corticosteroids or retinoids within 1 month prior to Visit 2/Baseline or during the study.
- Subject has used treatment with PDT (photodynamic therapy) or physical therapies (e. g. cryotherapy, curettage or surgical treatment) in the treatment area within 1 month prior to Visit 2/Baseline or during the study.
- Subject has used chemical peel, dermabrasion, laser abrasion, PUVA (prosalen plus ultraviolet A) therapy or UVB therapy within 6 months prior to Visit 2/Baseline or during the study.
- Subject has used immunomodulators or immunosuppressive therapies, interferon, oral corticosteroids, oral retinoids or cytotoxic drugs within 1 month prior to Visit 2/Baseline or during the study.
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 |
|---|---|---|
| AM001 Cream, 7.5%Also: Potassium DobesilateActive Cream | Drug | AM001 Cream, 7.5% |
| Vehicle CreamAlso: Placebo CreamPlaceo | Drug | Vehicle Cream |
Primary outcome
Complete clearance of all lesions
Time frame: 8 weeks post treatment
(100 % of all AK lesions cleared) 8 weeks post treatment
3 secondary outcomes
Complete clearance of all baseline lesions weeks of treatment
Time frame: 16 weeks
Complete clearance of all lesions
Time frame: 12 weeks
Complete clearance of all lesions
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AM001 Cream, 7.5% in people with Actinic Keratosis, run by AmDerma at 1 site 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 7 inclusion and 14 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete clearance of all lesions (time frame: 8 weeks post treatment). 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 30 Apr 2019.