Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
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ClinicalTrials.gov Identifier: NCT01270971 |
Recruitment Status :
Completed
First Posted : January 6, 2011
Results First Posted : August 15, 2014
Last Update Posted : February 22, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Onychomycosis of Toenails | Drug: AN2690 Topical Solution, 5% Drug: Solution Vehicle | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 594 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of AN2690 Topical Solution, 5%, vs. Solution Vehicle in the Treatment of Onychomycosis of the Toenail in Adults |
Actual Study Start Date : | December 1, 2010 |
Actual Primary Completion Date : | November 30, 2012 |
Actual Study Completion Date : | January 8, 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%
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Drug: AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%, applied once daily for 48 weeks |
Placebo Comparator: Solution Vehicle
Solution Vehicle
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Drug: Solution Vehicle
AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks |
- Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 [ Time Frame: Week 52 ]No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
- Completely Clear or Almost Clear Target Great Toenail at Week 52 [ Time Frame: Week 52 ]No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.
- Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 [ Time Frame: Week 52 ]No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
- Negative Mycology of Target Great Toenail at Week 52 [ Time Frame: Week 52 ]Negative KOH and negative fungal culture.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail
- KOH positive at screening
- Willingness not to use any other products including nail polish applied to the toenails during the study
- Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period
Exclusion Criteria:
- Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
- History of any significant chronic fungal disease other than onychomycosis
- Significant confounding conditions as assessed by study doctor
- Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- Pregnancy or lactation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270971

Study Director: | PfizerCT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01270971 History of Changes |
Other Study ID Numbers: |
AN2690-ONYC-301 |
First Posted: | January 6, 2011 Key Record Dates |
Results First Posted: | August 15, 2014 |
Last Update Posted: | February 22, 2019 |
Last Verified: | February 2019 |
Onychomycosis nail fungus toenail fungus fungal nail hyperkeratosis nail infection nail treatment toenail infection toenail treatment foot dermatoses fungal culture onycholysis podiatrist podiatry |
subungual tinea unguium antifungal anti-fungal dermatologist dermatology dermatophyte distal subungual onychomycosis yellow nail thick nail brittle nail crumbling nail discolored nail weak nail |
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious Infection Mycoses |
Nail Diseases Skin Diseases Tavaborole Pharmaceutical Solutions Antifungal Agents Anti-Infective Agents |