Actinic Keratosis (AK)Phase 2/3NCT03116698

A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period

A Phase 2/3 study testing Low dose DFD07 once daily, High dose DFD07 once daily and High dose DFD07 twice daily in people with Actinic Keratosis (AK), run by Dr. Reddy's Laboratories Limited at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to treatment in one of four arms. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Actinic Keratosis (AK)
What is being tested?: Low dose DFD07 once daily, High dose DFD07 once daily and High dose DFD07 twice daily
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 20 sitesUnited States
Study dates: 14 Feb 2017to 5 Jul 2018
Phase: Phase 2/3
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects with a legal guardian, must have the written informed consent of the legal guardian.
Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study.
Subjects must have 5 or more AK lesions that are non-hypertrophic and non-hyperkeratotic, contained within a single contiguous approximately 5 cm x 5 cm (25 cm2) region of face and/or scalp.
Subjects must be 18 years of age or older. Male and female subjects can be enrolled.
Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment.
A female is considered of childbearing potential unless she is:

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postmenopausal for at least 12 months prior to study product administration;
without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 6 months prior to study product administration.
Reliable methods of contraception are:
hormonal methods or intrauterine device in use more than 90 days prior to study product administration; or
barrier methods plus spermicide in use at least 14 days prior to study product administration.
partner has had a vasectomy at least 3 months previous to study product administration.
Essure
Exception: Sexually inactive female subjects of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the investigator's discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study. An abstinent female must agree that if she becomes sexually active during the study she will use an acceptable form of contraception.
Subjects must agree not to use any product on the treatment area during the entire course of study except for Investigator-approved cleanser, sunscreen, wash, and non-medicated make-up. Subjects should continue to use these Investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
Subjects must be willing to comply with sun avoidance measures for the face including use of Investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.
Subjects must be in good general health as determined by the Investigator and supported by the medical history, and normal or not clinically significant abnormal vital signs (blood pressure and pulse rate). Subjects are eligible if:
Systolic blood pressure (BP) < 160 and > 85 mmHg
Diastolic BP < 100 and > 50 mmHg

Who cannot join

Known or suspected hypersensitivity to any non-steroidal anti-inflammatory drugs (NSAID) or any component of the formulation of the study medication, including a history of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDs.
Known or suspected allergy to sulfonamides.
Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.
Recent (within 6 months) or planned coronary artery bypass graft surgery.
Significant history (within the past year) of alcohol or drug abuse.
Participation in any clinical research study within 30 days of the Baseline Visit.

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Concomitant use of cosmetics or other topical drug products on or near the selected treatment area, except for Investigator-approved cleanser, sunscreen, wash, and non-medicated makeup.
Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within 2 weeks and within 2 cm of the selected treatment area.
Other skin conditions within the selected treatment area (e.g. rosacea, psoriasis, atopic dermatitis, eczema, basal or squamous cell carcinoma or albinism).
Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit.
Females who are pregnant or lactating or planning to become pregnant during the study period.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Investigator Site 10
Austin, Texas, 78660
Investigator Site 16
Boca Raton, Florida, 33486
Investigator Site 3
Cerritos, California, 90703
Investigator Site 14
Fort Washington, Pennsylvania, 19034
Investigator Site 1
Fremont, California, 94538
Investigator Site 4
Houston, Texas, 77055
Investigator Site 8
Lake City, Florida, 32055
Investigator Site 7
Miami, Florida, 33126
Investigator Site 19
Miami, Florida, 33162
Investigator Site 20
Miami Lakes, Florida, 33016
Investigator Site 17
Ormond Beach, Florida, 32174
Investigator Site 9
Palm Springs, California, 92262
Investigator Site 5
Plano, Texas, 75024
Investigator Site 11
San Antonio, Texas, 78229
Investigator Site 2
San Antonio, Texas, 78229
Investigator Site 12
San Antonio, Texas, 78249
Investigator Site 18
Santa Ana, California, 92701
Investigator Site 15
Stony Brook, New York, 11790
Investigator Site 13
Verona, New Jersey, 07044
Investigator Site 6
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Evaluate the Dose-Response Relationship of the Efficacy and Safety of Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period.

Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to treatment in one of four arms.

Conditions: Actinic Keratosis (AK)
Being tested: Low dose DFD07 once daily, High dose DFD07 once daily, High dose DFD07 twice daily, Placebo twice daily
Medical subject headings: Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low dose DFD07 once dailyDrug
Low dose DFD07 once daily
High dose DFD07 once dailyDrug
High dose DFD07 once daily
High dose DFD07 twice dailyDrug
High dose DFD07 twice daily
Placebo twice dailyDrug
Placebo twice daily

Study groups in NCT03116698
Study group	Role	What they receive
Low dose DFD07 once daily	Experimental	Not described Receives: Drug: Low dose DFD07 once daily
High dose DFD07 once daily	Experimental	Not described Receives: Drug: High dose DFD07 once daily
High dose DFD07 twice daily	Experimental	Not described Receives: Drug: High dose DFD07 twice daily
Placebo twice daily	Placebo comparator	Not described Receives: Drug: Placebo twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks
The proportion of subjects with complete clearance (absence of clinically visible or palpable AK lesions in the treatment area) of AK lesions at the End of Study Visit at 16 weeks (12 weeks treatment and 4 weeks treatment-free follow-up)
Measured: 16 Weeks

Secondary outcomes (1)

Proportion of Subjects With Partial Clearance at Week 16
Proportion of subjects with partial clearance of AK lesions at week 16 (12 weeks treatment and 4 weeks treatment free follow up period)
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20175 Jul 2018

First posted17 Apr 2017
Study start14 Feb 2017
Primary completion13 Nov 2017
Study completion5 Jul 2018

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 Keratosis (AK)Studies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03116698
Sponsor's protocol ID: DFD-07-CD-002
Status last verified: Apr 2019
First submitted: 12 Apr 2017
Last updated: 24 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
RecruitingPhase 1
An Open-Label Pharmacokinetic Study for Patients With Actinic Keratosis on the Upper Extremities or the Face
Actinic Keratosis (AK)
Active, not recruitingPhase 1/2
Evaluate RLS-1496 Topical Cream for Actinic Keratosis
Actinic Keratosis (AK)
RecruitingObservational study
Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)
Actinic Keratosis (AK)
RecruitingEarly Phase 1
A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients
Skin Cancer, Cutaneous Squamous Cell Carcinoma (CSCC)

All Actinic Keratosis (AK) trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Evaluate the Dose-Response Relationship of the Efficacy and Safety of Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period.
ClinicalTrials.gov ID: NCT03116698
Acronym / sponsor ID: DFD-07-CD-002
Conditions: Actinic Keratosis (AK)
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
Study start: 14 Feb 2017 (actual)
Primary completion: 13 Nov 2017 (actual)
Study completion: 5 Jul 2018 (actual)
First posted: 17 Apr 2017 (actual)
Results: Posted 24 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to treatment in one of four arms.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Low dose DFD07 once daily	Experimental	Drug: Low dose DFD07 once daily
High dose DFD07 once daily	Experimental	Drug: High dose DFD07 once daily
High dose DFD07 twice daily	Experimental	Drug: High dose DFD07 twice daily
Placebo twice daily	Placebo comparator	Drug: Placebo twice daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Subject understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects with a legal guardian, must have the written informed consent of the legal guardian.
Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study.
Subjects must have 5 or more AK lesions that are non-hypertrophic and non-hyperkeratotic, contained within a single contiguous approximately 5 cm x 5 cm (25 cm2) region of face and/or scalp.
Subjects must be 18 years of age or older. Male and female subjects can be enrolled.
Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment.

Key exclusion criteria (11 listed)

Known or suspected hypersensitivity to any non-steroidal anti-inflammatory drugs (NSAID) or any component of the formulation of the study medication, including a history of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDs.
Known or suspected allergy to sulfonamides.
Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.
Recent (within 6 months) or planned coronary artery bypass graft surgery.
Significant history (within the past year) of alcohol or drug abuse.

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
Low dose DFD07 once dailyLow dose DFD07 once daily	Drug	Low dose DFD07 once daily
High dose DFD07 once dailyHigh dose DFD07 once daily	Drug	High dose DFD07 once daily
High dose DFD07 twice dailyHigh dose DFD07 twice daily	Drug	High dose DFD07 twice daily
Placebo twice dailyPlacebo twice daily	Drug	Placebo twice daily

Primary outcome

Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks
Time frame: 16 Weeks
The proportion of subjects with complete clearance (absence of clinically visible or palpable AK lesions in the treatment area) of AK lesions at the End of Study Visit at 16 weeks (12 weeks treatment and 4 weeks treatment-free follow-up)

1 secondary outcome

Proportion of Subjects With Partial Clearance at Week 16
Time frame: 16 weeks

Results and safety

Results posted to the registry on 24 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DFD07 - 1.25% Once Daily	62	56
DFD07 - 2.5% Once Daily	57	51
DFD07 - 2.5% Twice Daily	62	54
Vehicle Twice Daily	57	55

Primary outcome: Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks

Time frame: 16 Weeks. Count of participants. Unit: Participants

Measure	DFD07 Cream (Celecoxib 1.25%) Once Daily n = 62	DFD07 Cream (Celecoxib 2.5%) Once Daily n = 57	DFD07 Cream (Celecoxib 2.5%) Twice Daily n = 62	Vehicle Cream (Celecoxib 0%) Twice Daily n = 57
Value	6	9	10	7

Population analysed: Intent To Treat (ITT) population defined as all subjects who were randomized and dispensed study medication.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DFD07 Cream (Celecoxib 1.25%) Once Daily	0 of 62 (0%)	18 of 62 (29%)	0 of 62
DFD07 Cream (Celecoxib 2.5%) Once Daily	0 of 57 (0%)	8 of 57 (14%)	0 of 57
DFD07 Cream (Celecoxib 2.5%) Twice Daily	2 of 62 (3.2%)	21 of 62 (33.9%)	2 of 62
Vehicle Cream (Celecoxib 0%) Twice Daily	0 of 57 (0%)	11 of 57 (19.3%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Actinic Keratosis (AK)

Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
RecruitingPhase 1
An Open-Label Pharmacokinetic Study for Patients With Actinic Keratosis on the Upper Extremities or the Face
Actinic Keratosis (AK)
Active, not recruitingPhase 1/2
Evaluate RLS-1496 Topical Cream for Actinic Keratosis
Actinic Keratosis (AK)
RecruitingObservational study
Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)
Actinic Keratosis (AK)
RecruitingEarly Phase 1
A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients
Skin Cancer, Cutaneous Squamous Cell Carcinoma (CSCC)

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.

Srinivas R. Sidgiddi, M.D. study director

Dr. Reddy's Laboratories

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 inclusion and 11 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 24 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 20 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 combined 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.

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 24 Apr 2019). 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?

Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks (time frame: 16 Weeks). 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 NCT03116698.

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 24 Apr 2019.