Actinic KeratosisPhase 3NCT03037541
Cryosurgery and Cream Combination for Actinic Keratosis
A Phase 3 study testing Carac Cream in people with Actinic Keratosis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as tolerated, though local irritation often occurs within the first week of treatment and increases in a dose-dependent manner. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Carac Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2011to 29 Oct 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be male or female and at least 18 years of age. Each subject must demonstrate good health as determined by a baseline medical history.
- Female subjects myst be of either non-childbearing potential, or childbearing potential provided: negative urine pregnancy test and using two acceptable methods of effective contraception (abstinence, birth control pills.patch, DepoProvera, tubal ligation, vasectomy of the partner in a monogamous relationship, condoms and spermicidal form or gel and/or cervical cap or sponge), as determined by the investigator
- At least eight clinically typical, visible and discrete AK lesions within the treatment area on the face or balding scalp
- Subjects must be able and willing to comply with study procedures and have provided written informed consent.
Who cannot join
- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the selected treatment area in the previous four weeks.
- Treatment with systemic medications that suppress the immune system within the previous four weeks.
- Field treatments with topical 5-FU, imiquimod, diclofenac, or photodynamic therapy, or more widespread field treatment with dermabrasion, medium or greater depth chemical peel, or laser resurfacing within the previous six months.
- Any known dihydropyrimidine dehydrogenase enzyme deficiency.
- In addition, subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation as determined by the investigator, or a history of hypersensitivity to any of the formulation components will be excluded from study.
- Subjects may not use other topical agents such as glycolic acid products, alpha-hydroxy acid products, retinoids and chemical peel agents on teh treatment area while on study. The use of these products are not allowed four weeks prior to study enrollment. Introduction of any other prescription medication, topical or systemic for actinic keratosis while participating in the study is not permitted.
- Pregnant women, women who are breast feeding, or women of childbearing potential who are not practicing two acceptable methods of effective contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157
About this study
Official title: A Single-Center, Randomized, Single-Blinded, Placebo-Controlled Trial on the Efficacy of Cryosurgery and 5-Fluorouracil 0.5% Cream Combination Therapy for the Treatment of Actinic Keratosis
Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as tolerated, though local irritation often occurs within the first week of treatment and increases in a dose-dependent manner. In this study, the investigators will examine the combination of standard cryosurgery treatment followed by a shortened course of topical fluorouracil cram. The investigators anticipate that a one week treatment course will maintain overall effectiveness when combined with previous cryosurgery, but will reduce the overall adverse effects of topical therapy due to the reduced treatment time and the presence of fewer baseline lesions to treat. This treatment approach may provide a more acceptable risk/benefit ratio option for patients with more extensive disease and simplify standard combination treatment options. The primary objective is to evaluate the efficacy of combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and placebo in the treatment of actinic keratosis lesions. The efficacy of this combination therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.
Read the detailed description
This is a randomized (1:1), single-blind, placebo controlled, single center prospective study. Subjects will first undergo cryosurgery of all clinically apparent AK lesions, limited to the face or balding scalp. Three weeks after cryosurgery, subjects will then be randomized (1:1 according to standard randomization tables) and directed to apply either Carac 0.5% cream or placebo cream (Cetaphil Cream) to the face or balding scalp at bedtime for seven consecutive days, washed off each following morning. Each does of study cream will be applied at approximately the same time of day and will remain on the skin for approximately eight hours. Subject evaluation, Investigator Global Assessments, Quality of Life lesion counts and photography shall be performed at Baseline. At Week 3, study drug will be dispensed and the global assessments and assessment of improvement will be performed. A Medication Tolerability Assessment will occur at Week 4 when the study drug will be returned. Investigator Global Assessment, lesion count, Global Assessment of Improvement and Quality of Life will be measured at Week 8 and Week 26 (or end of study). Photography will be done at Week 26 or end of study.
- Conditions
- Actinic Keratosis
- Being tested
- Carac Cream, Placebo Cetaphil cream
- Keywords
- Wake Forest, Actinic Keratosis, Cryosurgery, 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.
Carac CreamDrug
Carac Cream will be used once daily for seven consecutive days
Placebo Cetaphil creamDrug
Also called Cetaphil
Placebo Cetaphil Cream will be used once daily for seven consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Carac (fluorouracil) 0.5% cream | Experimental | Carac cream (fluorouracil) 0.5% applied daily on the face for one week Receives: Drug: Carac Cream |
| Group 2 Placebo | Placebo comparator | Placebo Cetaphil cream applied daily on the face for one week Receives: Drug: Placebo Cetaphil cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Participants With 100% Clearance
The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment
Measured: 24 weeks
Secondary outcomes (1)
Number of Participants With 75% Clearance
The secondary endpoint is number of participants that receive 75 % clearance of
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start5 Jan 2011
- Primary completion29 Oct 2013
- Study completion29 Oct 2013
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Jorizzo, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037541
- Sponsor's protocol ID
- IRB00014209
- Status last verified
- Jul 2018
- First submitted
- 8 Sep 2011
- Last updated
- 29 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Single-Blinded, Placebo-Controlled Trial on the Efficacy of Cryosurgery and 5-Fluorouracil 0.5% Cream Combination Therapy for the Treatment of Actinic Keratosis
- ClinicalTrials.gov ID
- NCT03037541
- Acronym / sponsor ID
- IRB00014209
- Conditions
- Actinic Keratosis
- Keywords
- Wake Forest, Actinic Keratosis, Cryosurgery, Cream
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 5 Jan 2011 (actual)
- Primary completion
- 29 Oct 2013 (actual)
- Study completion
- 29 Oct 2013 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as tolerated, though local irritation often occurs within the first week of treatment and increases in a dose-dependent manner. In this study, the investigators will examine the combination of standard cryosurgery treatment followed by a shortened course of topical fluorouracil cram. The investigators anticipate that a one week treatment course will maintain overall effectiveness when combined with previous cryosurgery, but will reduce the overall adverse effects of topical therapy due to the reduced treatment time and the presence of fewer baseline lesions to treat. This treatment approach may provide a more acceptable risk/benefit ratio option for patients with more extensive disease and simplify standard combination treatment options. The primary objective is to evaluate the efficacy of combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and placebo in the treatment of actinic keratosis lesions. The efficacy of this combination therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.
Detailed description
This is a randomized (1:1), single-blind, placebo controlled, single center prospective study. Subjects will first undergo cryosurgery of all clinically apparent AK lesions, limited to the face or balding scalp. Three weeks after cryosurgery, subjects will then be randomized (1:1 according to standard randomization tables) and directed to apply either Carac 0.5% cream or placebo cream (Cetaphil Cream) to the face or balding scalp at bedtime for seven consecutive days, washed off each following morning. Each does of study cream will be applied at approximately the same time of day and will remain on the skin for approximately eight hours. Subject evaluation, Investigator Global Assessments, Quality of Life lesion counts and photography shall be performed at Baseline. At Week 3, study drug will be dispensed and the global assessments and assessment of improvement will be performed. A Medication Tolerability Assessment will occur at Week 4 when the study drug will be returned. Investigator Global Assessment, lesion count, Global Assessment of Improvement and Quality of Life will be measured at Week 8 and Week 26 (or end of study). Photography will be done at Week 26 or end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Carac (fluorouracil) 0.5% cream | Experimental | Drug: Carac CreamCarac cream (fluorouracil) 0.5% applied daily on the face for one week |
| Group 2 Placebo | Placebo comparator | Drug: Placebo Cetaphil creamPlacebo Cetaphil cream applied daily on the face for one week |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be male or female and at least 18 years of age. Each subject must demonstrate good health as determined by a baseline medical history.
- Female subjects myst be of either non-childbearing potential, or childbearing potential provided: negative urine pregnancy test and using two acceptable methods of effective contraception (abstinence, birth control pills.patch, DepoProvera, tubal ligation, vasectomy of the partner in a monogamous relationship, condoms and spermicidal form or gel and/or cervical cap or sponge), as determined by the investigator
- At least eight clinically typical, visible and discrete AK lesions within the treatment area on the face or balding scalp
- Subjects must be able and willing to comply with study procedures and have provided written informed consent.
Key exclusion criteria (7 listed)
- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the selected treatment area in the previous four weeks.
- Treatment with systemic medications that suppress the immune system within the previous four weeks.
- Field treatments with topical 5-FU, imiquimod, diclofenac, or photodynamic therapy, or more widespread field treatment with dermabrasion, medium or greater depth chemical peel, or laser resurfacing within the previous six months.
- Any known dihydropyrimidine dehydrogenase enzyme deficiency.
- In addition, subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation as determined by the investigator, or a history of hypersensitivity to any of the formulation components will be excluded from 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 |
|---|---|---|
| Carac CreamCarac Cream will be used once daily for seven consecutive days | Drug | Group 1 Carac (fluorouracil) 0.5% cream |
| Placebo Cetaphil creamAlso: CetaphilPlacebo Cetaphil Cream will be used once daily for seven consecutive days | Drug | Group 2 Placebo |
Primary outcome
Number Participants With 100% Clearance
Time frame: 24 weeks
The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment
1 secondary outcome
Number of Participants With 75% Clearance
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Joseph Jorizzo, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carac Cream in people with Actinic Keratosis, run by Wake Forest University Health Sciences 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 4 inclusion and 7 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 29 Aug 2018. 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 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 23 Mar 2017). 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?
Number Participants With 100% Clearance (time frame: 24 weeks). 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 29 Aug 2018.