A Phase 3 interventional study of imiquimod and Aldara™ in Actinic Keratoses, sponsored by Actavis Inc.. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-04.
Sponsored by Actavis Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
Among 23 studies testing imiquimod in Keratosis, Actinic — 1 open to participants now, 1 under way, 1 of them phase 3. Imiquimod · Keratosis, Actinic.
Among the 23 studies testing imiquimod in Keratosis, Actinic, this one is the 8th largest by enrollment of the 22 interventional ones that give a count, is one of 7 that started in 2008, is one of 9 in phase 3, and was the 14th registered.
343 studies on the registry are indexed under Keratosis, Actinic; 29 are open to participants now.
Browse Keratosis, Actinic studies →1 of the 23 studies testing imiquimod in Keratosis, Actinic is open now, in 1 country. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
By country, each count listing its studies:
Imiquimod: first FDA approval 1997 (ALDARA), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →
Of the 21 Keratosis, Actinic studies recruiting now, 16 (76%) set no upper age limit and 1 (5%) stop at 75 or younger; 0 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 7 started in 2008.
This study's enrollment of 462 is above the median of 60 across 295 interventional studies indexed under Keratosis, Actinic.
Median enrollment 253 across the 22 interventional studies. Of the 19 that completed or were terminated, 9 (47%) have results posted.
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16 of 23 have an industry lead sponsor. The 10 most frequent:
Actavis Inc. is the lead sponsor of 95 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Actavis Inc. has 6 studies filed under Keratosis, Actinic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies testing imiquimod in Keratosis, Actinic, from their registry updates:
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At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.
A nationwide, multicenter, double-blind, vehicle-controlled parallel group comparison study of a Generic Imiquimod cream, 5% (Actavis Mid-Atlantic LLC) and currently marketed Aldara (imiquimod) cream, 5% (distributed by Graceway Pharmaceuticals, LLC) was conducted in subjects with actinic keratoses (AKs) on the face and/or anterior scalp in order to evaluate the therapeutic equivalence of these two active treatments and to establish superiority of the efficacy of these two products over a Vehicle cream. Subjects were randomized to one of three treatment groups on a 2:2:1 basis as follows: (1) Generic Imiquimod cream, 5%, (2) Aldara (imiquimod) cream, 5%, and (3) Vehicle cream. The duration of treatment was 16 weeks (± 7 days).
The primary efficacy endpoint was the proportion of subjects in each treatment group with Complete Clearance (having no clinically visible actinic keratosis lesions in the 25 cm2 contiguous treatment area at the 8-week post-treatment visit) of AK lesions. The secondary efficacy endpoints were the Partial Clearance rates, defined as the proportion of subjects with at least a 75% reduction in the number of AK lesions counted at Baseline at the end-of-treatment visit (Week 16, EOT) and at the 8 weeks post-treatment visit/test-of-cure (Week 24, TOC), and the proportion of subjects with Complete Clearance of AK lesions at the end-of-treatment (Week 16, EOT) visit.
A 90% Wald's confidence interval with Yate's continuity correction was constructed around the difference between the proportions of subjects with Complete Clearance of AK lesions in the active treatments (Generic Imiquimod minus Aldara) to evaluate therapeutic equivalence in the primary efficacy analyses. Two-sided, continuity-corrected statistics were used to evaluate the superiority of each active treatment's Complete Clearance rate over that of the Vehicle treatment. The therapeutic comparability evaluations in the per-protocol (PP) population were considered primary while those in the intent-to-treat (ITT) population were considered supportive. The superiority comparisons in the ITT population were considered primary while those in the PP population were considered supportive. If the 90% confidence interval (CI) around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the PP population were contained within the interval 0.20 to +0.20, and each of these rates was greater than, and statistically different (p\<0.05) from, the Vehicle rate in the ITT population, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.
Secondary efficacy analyses were conducted on the proportion of subjects in each treatment group with Complete Clearance of AK lesions at the Week 16, EOT visit as well as evaluation of the Partial Clearance of AK lesions at both the EOT and TOC visits. The results at both the EOT visit (Week 16) and those at 8 weeks post-treatment (Week 24, TOC) were statistically analyzed by the same methods described for the primary efficacy variable.
Both EOT and TOC analyses were conducted in the ITT population. The TOC analysis was conducted in the PP population and the EOT analysis was conducted in the EOT PP population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial topical medications: , alpha- hydroxyacids (e.g., glycolic acid, lactic acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea - greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face and/or anterior scalp.
Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.
Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens, immunotherapy, or retinoids.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
imiquimod cream, 5%
Drug: imiquimod
Aldara™ (imiquimod) cream, 5%
Drug: Aldara™
Vehicle cream (Actavis)
Drug: Vehicle Cream
5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
Percentage of Subjects in Each Treatment Group With Complete Clearance of AK Lesions at the Test of Cure Visit (Week 24)
Time frame: Week 24
Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to End of Treatment (EOT) Visit (Week 16).
Time frame: Week 16
Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to 8 Weeks Post Treatment (Test of Cure Visit).
Time frame: Week 24
| Milestone | Generic Imiquimod | Aldara™ | Vehicle Cream |
|---|---|---|---|
| Started | 185 | 185 | 92 |
| Completed | 167 | 167 | 84 |
| Not completed | 18 | 18 | 8 |
| Withdrew: Withdrawal by subject | 6 | 12 | 7 |
| Withdrew: Adverse event | 6 | 3 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 |
| Withdrew: Death | 2 | 0 | 0 |
| Withdrew: Intercurrent illness | 1 | 0 | 0 |
| Withdrew: Non-compliance | 1 | 2 | 0 |
| Participants | Generic Imiquimod | Aldara™ | Vehicle Cream |
|---|---|---|---|
| Percentage of Subjects in Each Treatment Group With Complete Clearance of AK Lesions at the Test of Cure Visit (Week 24) | 74 | 72 | 7 |
| Participants | Generic Imiquimod | Aldara™ | Vehicle Cream |
|---|---|---|---|
| Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to End of Treatment (EOT) Visit (Week 16). | 110 | 114 | 14 |
| Participants | Generic Imiquimod | Aldara™ | Vehicle Cream |
|---|---|---|---|
| Percentage of Subjects With at Least a 75% Reduction in the Number of AK Lesions From Baseline to 8 Weeks Post Treatment (Test of Cure Visit). | 77 | 77 | 7 |
Collected over 24 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Generic Imiquimod | 1/181 (0.6%) | 4/181 (2.2%) | 79/181 (43.6%) |
| Aldara™ | 0/179 (0%) | 2/179 (1.1%) | 60/179 (33.5%) |
| Vehicle Cream | 0/89 (0%) | 2/89 (2.2%) | 25/89 (28.1%) |
| Event | Generic Imiquimod | Aldara™ | Vehicle Cream |
|---|---|---|---|
| Chest painGeneral disorders | 0/181 | 0/179 | 1/89 |
| Gastrointestinal neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/181 | 0/179 | 1/89 |
| Carotid artery atenosisNervous system disorders | 0/181 | 0/179 | 1/89 |
| AppendicitisInfections and infestations | 0/181 | 1/179 | 0/89 |
| Hip fractureInjury, poisoning and procedural complications | 0/181 | 1/179 | 0/89 |
| AnaemiaBlood and lymphatic system disorders | 1/181 | 0/179 | 0/89 |
| Acute myocardial infarctionCardiac disorders | 1/181 | 0/179 | 0/89 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/181 | 0/179 | 0/89 |
| Mixed hepatocellular cholangiocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/181 | 0/179 | 0/89 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/181 | 0/179 | 0/89 |
| Event | Generic Imiquimod | Aldara™ | Vehicle Cream |
|---|---|---|---|
| NauseaGastrointestinal disorders | 1/181 | 7/179 | 0/89 |
| NasopharyngitisInfections and infestations | 5/181 | 6/179 | 3/89 |
| Squamous cell carcinoma of skinNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/181 | 2/179 | 3/89 |
| SinusitisInfections and infestations | 6/181 | 1/179 | 1/89 |
| HeadacheNervous system disorders | 6/181 | 5/179 | 2/89 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/181 | 3/179 | 2/89 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 5/181 | 0/179 | 1/89 |
| Urinary tract infectionInfections and infestations | 1/181 | 4/179 | 0/89 |
| MyalgiaMusculoskeletal and connective tissue disorders | 4/181 | 1/179 | 0/89 |
| LethargyNervous system disorders | 2/181 | 3/179 | 0/89 |
Using Intent-to-Treat Population
| Age, Continuous(years) | Generic Imiquimod | Aldara™ | Vehicle Cream | Total |
|---|---|---|---|---|
| Mean | 66.5 ± 10.1 | 66.7 ± 10.4 | 66.7 ± 9.9 | 66.6 ± 10.1 |
| Sex: Female, Male(Participants) | Generic Imiquimod | Aldara™ | Vehicle Cream | Total |
|---|---|---|---|---|
| Female | 29 | 20 | 13 | 62 |
| Male | 152 | 159 | 76 | 387 |
| Ethnicity (NIH/OMB)(Participants) | Generic Imiquimod | Aldara™ | Vehicle Cream | Total |
|---|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 2 | 13 |
| Not Hispanic or Latino | 176 | 173 | 87 | 436 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Generic Imiquimod | Aldara™ | Vehicle Cream | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 181 | 179 | 89 | 449 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
The record gives a start of May 2008, a primary completion of Mar 2009 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2020, 11 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Imiquimod