Actinic KeratosisPhase 3NCT03285490
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
A Phase 3 study testing KX2-391 Ointment 1% in people with Actinic Keratosis, run by Almirall, S.A. at 30 sites in United States.
Trial summary
This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- KX2-391 Ointment 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 30 sitesUnited States
- Study dates
- 15 Sep 2017to 24 Apr 2019
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females greater than or equal to (>=) 18 years old.
- A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and discrete AK lesions.
- Participants who in the judgment of the Investigator, were in good general health.
- Females were postmenopausal (greater than [>] 45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of childbearing potential, were using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever was longer, prior to study treatment and agreed to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device or complete abstinence from sexual intercourse.
- Sexually active males who had not had a vasectomy, and whose partner was reproductively capable, must had agreed to use barrier contraception from Screening through 90 days after their last dose of study treatment.
- All participants must had agreed not to donate sperm or eggs or attempt conception from Screening through 90 days following their last dose of study treatment.
- Willing to avoid excessive sun or ultraviolet exposure.
- Able to comprehend and were willing to sign the informed consent form (ICF).
Who cannot join
- Clinically atypical and/or rapidly changing AK lesions on the treatment area.
- Location of the selected area is:
- On any location other than the face or scalp.
- Within 5 centimeters (cm) of an incompletely healed wound.
- Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
- Been previously treated with KX2-391 Ointment.
Show all 21Show fewer
- Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57.
- Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit.
- Use of the following therapies and/or medications within 2 weeks prior to the Screening visit:
- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area.
- Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area.
- Topical salves (non-medicated/non-irritant lotion and cream were acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area.
- Use of the following therapies and/or medications within 4 weeks prior to the Screening visit:
- Treatment with immunomodulators (eg, azathioprine), cytotoxic drugs (eg, cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon inducers.
- Treatment with systemic medications that suppress the immune system (eg, cyclosporine, prednisone, methotrexate, alefacept, infliximab).
- Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit.
- A history of sensitivity and/or allergy to any of the ingredients in the study medication.
- A skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to unacceptable risk by study participation.
- Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation.
- Females who were pregnant or nursing.
- Participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever was longer, before dosing.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
DermResearch
Austin, Texas, 78759
Study Protocol, Inc
Boynton Beach, Florida, 33437
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Aventiv Research Inc.
Dublin, Ohio, 43016
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
AboutSkin Dermatology
Greenwood Village, Colorado, 80111
Henderson Dermatology Research
Henderson, Nevada, 89052
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Suzanne Bruce and Associates, P.A., The Center for Skin Research
Houston, Texas, 77056
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
Dermatology Associates Of Knoxville, PC
Knoxville, Tennessee, 37917
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, 70601
DS Research
Louisville, Kentucky, 40241
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
Sweet Hope Research Specialty, Inc.
Miami Lakes, Florida, 33016
Dermatology Specialists, Inc.
Murrieta, California, 92562
Union Square Laser Dermatology
New York, New York, 10003
Dermatology Specialists, Inc.
Oceanside, California, 92056
Alliance Dermatology
Phoenix, Arizona, 85032
Oregon Medical Research Center
Portland, Oregon, 97223
Activmed Practices & Research, Inc
Portsmouth, New Hampshire, 03801
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Skin Surgery Medical Group, Inc.
San Diego, California, 92117
Synexus
Santa Rosa, California, 95405
Dermatology Associates of Seattle
Seattle, Washington, 98101
Rivergate Dermatology Clinical Research
Springfield, Tennessee, 37072
Forward Clinical Trials, Inc.
Tampa, Florida, 33624
Synexus US
Tucson, Arizona, 85712
About this study
Official title: A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp
This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp.
Read the detailed description
This study was a double-blinded, multicenter, efficacy, and safety study of KX2-391 ointment administered topically to the face or scalp of participants with AK.
The study consisted of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received up to 5 consecutive days of topical treatment. Efficacy (lesion counts) and safety evaluations were performed.
- Conditions
- Actinic Keratosis
- Being tested
- KX2-391 Ointment 1%, Placebo
- Keywords
- Actinic Keratosis, Keratosis, Keratosis, Actinic, Precancerous Conditions, Neoplasms, Sun Damaged Skin, Actinic Keratoses
- Medical subject headings
- Keratosis, Actinic, Keratosis, Precancerous Conditions, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KX2-391 Ointment 1%Drug
Dose: 1% (250 mg single-use packets); Dosage form: Ointment; Route of administration: Topical
PlaceboDrug
Dosage form: Ointment; Route of administration: Topical
| Study group | Role | What they receive |
|---|---|---|
| KX2-391 Ointment 1% | Experimental | KX2-391 Ointment was applied once daily for 5 consecutive days on the face or scalp. Receives: Drug: KX2-391 Ointment 1% |
| Placebo | Placebo comparator | The Vehicle Ointment was applied once daily for 5 consecutive days on the face or scalp. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions
Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
Measured: Day 57
Secondary outcomes (11)
Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57
Partial clearance rate of AK lesions was defined as the percentage of participants with a greater than or equal to (>=) 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area.
Measured: Day 57
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57
Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp).
Measured: Days 8, 15, 29 and 57
Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57
Recurrence rate was estimated based on Kaplan-Meier method, with recurrence define as appearance of any AK lesions in the treatment area, including those recurred or newly identified.
Measured: 3, 6, 9 and 12 months post-Day 57
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. The LSR assessment was an Investigator's (or sub-investigator's) assessment of the following signs on the treatment area: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. The LSRs were graded on a 4-point scale ranging from 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense).
Measured: Day 57
Number of Participants With Pigmentation and Scarring in the Treatment Area
Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed.
Measured: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57
Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests
An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. TEAEs (serious and non-serious) were defined as either those AEs with onset after first dose or those pre-existing AEs that worsen after first dose. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
Measured: Baseline (Day 1 predose) up to Day 57
Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57
An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
Measured: From Day 57 up to 12-months post-Day 57
Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis
Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator.
Measured: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Vital Signs
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Measured: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Physical Examination
A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Measured: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.
Measured: From Baseline (Day 1 predose) 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 posted18 Sep 2017
- Study start15 Sep 2017
- Primary completion7 May 2018
- Study completion24 Apr 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study tested KX2-391 Ointment 1% against a placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Athenex, Inc.
- Responsible party
- Sponsor
- Investigators
- Jane Fang, MD, Study chair, Athenex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285490
- Sponsor's protocol ID
- KX01-AK-004
- Other IDs
- U1111-1191-8287
- Status last verified
- Feb 2021
- First submitted
- 7 Sep 2017
- Last updated
- 10 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blauvelt A, Kempers S, Lain E, Schlesinger T, Tyring S, Forman S, Ablon G, Martin G, Wang H, Cutler DL, Fang J, Kwan MR; Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021 Feb 11;384(6):512-520. doi: 10.1056/NEJMoa2024040.
PubMed 33567191
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp
- ClinicalTrials.gov ID
- NCT03285490
- Acronym / sponsor ID
- KX01-AK-004
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, Keratosis, Keratosis, Actinic, Precancerous Conditions, Neoplasms, Sun Damaged Skin, Actinic Keratoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Athenex, Inc.
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 10 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp.
Detailed description
This study was a double-blinded, multicenter, efficacy, and safety study of KX2-391 ointment administered topically to the face or scalp of participants with AK.
The study consisted of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received up to 5 consecutive days of topical treatment. Efficacy (lesion counts) and safety evaluations were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study tested KX2-391 Ointment 1% against a placebo.
| Arm | Type | Receives |
|---|---|---|
| KX2-391 Ointment 1% | Experimental | Drug: KX2-391 Ointment 1%KX2-391 Ointment was applied once daily for 5 consecutive days on the face or scalp. |
| Placebo | Placebo comparator | Drug: PlaceboThe Vehicle Ointment was applied once daily for 5 consecutive days on the face or scalp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females greater than or equal to (>=) 18 years old.
- A defined area on the face or scalp contains 4 to 8 clinically typical, visible, and discrete AK lesions.
- Participants who in the judgment of the Investigator, were in good general health.
- Females were postmenopausal (greater than [>] 45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of childbearing potential, were using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever was longer, prior to study treatment and agreed to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device or complete abstinence from sexual intercourse.
- Sexually active males who had not had a vasectomy, and whose partner was reproductively capable, must had agreed to use barrier contraception from Screening through 90 days after their last dose of study treatment.
Key exclusion criteria (21 listed)
- Clinically atypical and/or rapidly changing AK lesions on the treatment area.
- Location of the selected area is:
- Been previously treated with KX2-391 Ointment.
- Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57.
- Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening 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 |
|---|---|---|
| KX2-391 Ointment 1%Dose: 1% (250 mg single-use packets); Dosage form: Ointment; Route of administration: Topical | Drug | KX2-391 Ointment 1% |
| PlaceboDosage form: Ointment; Route of administration: Topical | Drug | Placebo |
Primary outcome
Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions
Time frame: Day 57
Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
11 secondary outcomes
Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57
Time frame: Day 57
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57
Time frame: Days 8, 15, 29 and 57
Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57
Time frame: 3, 6, 9 and 12 months post-Day 57
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Time frame: Day 57
Number of Participants With Pigmentation and Scarring in the Treatment Area
Time frame: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57
Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests
Time frame: Baseline (Day 1 predose) up to Day 57
Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57
Time frame: From Day 57 up to 12-months post-Day 57
Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis
Time frame: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Vital Signs
Time frame: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Physical Examination
Time frame: From Baseline (Day 1 predose) up to Day 57
Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)
Time frame: From Baseline (Day 1 predose) 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 10 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33567191Blauvelt A, Kempers S, Lain E, Schlesinger T, Tyring S, Forman S, Ablon G, Martin G, Wang H, Cutler DL, Fang J, Kwan MR; Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021 Feb 11;384(6):512-520. doi: 10.1056/NEJMoa2024040.
- Individual participant dataSharing planned: No
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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.
Jane Fang, MD study chair
Athenex, Inc.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KX2-391 Ointment 1% in people with Actinic Keratosis, run by Almirall, S.A. at 30 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 8 inclusion and 21 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 10 Mar 2021). 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?
Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions (time frame: Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03285490, which also lists 1 linked publication.
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 10 Mar 2021.