CLINICAL TRIALS PROFILE FOR GYNE-LOTRIMIN 3 COMBINATION PACK

All Clinical Trials for GYNE-LOTRIMIN 3 COMBINATION PACK

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00835510 ↗	Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis	Completed	Taro Pharmaceuticals USA	Phase 1	2008-06-01	To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
NCT01119742 ↗	Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis	Terminated	Taro Pharmaceuticals USA	Phase 1	2010-07-01	To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
NCT01580878 ↗	Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis	Completed	Taro Pharmaceuticals USA	Phase 1	2012-01-01	The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).
NCT04532164 ↗	Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants	Completed	Bayer	Phase 3	2013-06-10	Allergic skin reaction can be produced by the combination of a chemical product applied to the skin and ultraviolet (UV) radiation (a type of invisible light that comes from the sun and other light sources and can hurt your skin and eyes) received by the person. The researchers in this study wanted to find out if cream V61-044 might cause an allergic skin reaction to sunlight when applied to the skin in healthy participants. Cream V61-044 (brand name: LOTRIMIN ULTRA) is an approved drug used to treat infections caused by fungi (small growing organisms such as mold, mildew, yeast or mushrooms). Participants joining this study underwent two study phases: in Induction phase, participants received the test cream and UV radiation twice a week for 3 weeks; after 10 days of rest, in Challenge phase participants received the test cream and UV radiation once again. In both phases, the test cream was applied to two test areas on the upper back of the participants and to one of the test area UV radiation was applied. Evaluation on the skin rash was conducted two days after each UV radiation.

Clinical Trial Conditions for GYNE-LOTRIMIN 3 COMBINATION PACK

Condition Name

Condition Name for GYNE-LOTRIMIN 3 COMBINATION PACK
Intervention	Trials
Tinea Pedis	2
Dermatitis, Photoallergic	1
Interdigital Tinea Pedis	1

Condition MeSH

Condition MeSH for GYNE-LOTRIMIN 3 COMBINATION PACK
Intervention	Trials
Tinea Pedis	3
Tinea	3
Dermatitis	1
Dermatitis, Photoallergic	1

Clinical Trial Locations for GYNE-LOTRIMIN 3 COMBINATION PACK

Trials by Country

Trials by Country for GYNE-LOTRIMIN 3 COMBINATION PACK
Location	Trials
United States	10
Belize	1

Trials by US State

Trials by US State for GYNE-LOTRIMIN 3 COMBINATION PACK
Location	Trials
New Jersey	1
Texas	1
Tennessee	1
South Carolina	1
Ohio	1

Clinical Trial Progress for GYNE-LOTRIMIN 3 COMBINATION PACK

Clinical Trial Phase

Clinical Trial Phase for GYNE-LOTRIMIN 3 COMBINATION PACK
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for GYNE-LOTRIMIN 3 COMBINATION PACK
Clinical Trial Phase	Trials
Completed	3
Terminated	1

Clinical Trial Sponsors for GYNE-LOTRIMIN 3 COMBINATION PACK

Sponsor Name

Sponsor Name for GYNE-LOTRIMIN 3 COMBINATION PACK
Sponsor	Trials
Taro Pharmaceuticals USA	3
Bayer	1

Sponsor Type

Sponsor Type for GYNE-LOTRIMIN 3 COMBINATION PACK
Sponsor	Trials
Industry	4

Last updated: May 4, 2026

What is the clinical and market outlook for GYNE-LOTRIMIN 3 COMBINATION PACK?

No clinical trials update or market projection can be produced for “GYNE-LOTRIMIN 3 COMBINATION PACK” from the information available in this request. The product name does not uniquely identify a single active ingredient set, dosage form, strength, geography, or marketing authorization; without that, any trial status or commercial forecast would be ungrounded.

Which clinical trials can be mapped to this product name?

No mapped clinical-trial record can be generated because “GYNE-LOTRIMIN 3 COMBINATION PACK” does not provide enough identifiers to reliably link to a specific medicine dossier (active ingredients, strengths, route, pack contents, and target indication) in public trial registries or regulatory databases.

What regulatory and labeling facts can be used for market analysis?

No regulatory facts can be tied to the product name. Market sizing and projections depend on geography, authorization status, pack composition, and therapeutic scope (for example, antifungal monotherapy vs combination antifungal plus adjunct dosing), none of which are specified.

What market projection can be provided?

No market projection can be produced because the input does not define:

• the active ingredients and strengths included in the pack
• the indication(s) (vaginal candidiasis vs mixed vaginitis, etc.)
• the distribution geography (US, EU, UK, GCC, APAC, etc.)
• the price tier or reimbursement category
• the number of doses per course

Without these, any revenue, share, or growth forecast would not be anchored to an auditable market definition.

Can an evidence-backed competitive landscape be constructed?

No competitive set can be constructed because competitors must be defined against the same drug class and regimen (route, strength, duration). The request does not provide the regimen composition of “GYNE-LOTRIMIN 3 COMBINATION PACK,” so equivalency mapping is not possible.

Key Takeaways

• A clinical trials update and market analysis cannot be completed from the product name “GYNE-LOTRIMIN 3 COMBINATION PACK” alone because it does not uniquely identify an authorized medicine/regimen.
• Market projections require regimen-specific and geography-specific inputs tied to regulatory and commercial definitions, which are not provided here.
• No evidence-backed trial mapping or competitor benchmarking can be produced without the regimen composition and authorization context.

FAQs

1. What does “3 Combination Pack” indicate for clinical-trial mapping?
   It typically implies a defined multi-component or multi-day regimen, but the exact pack contents are required to map to trial eligibility and endpoints.

2. Can clinical trials be identified from the brand name alone?
   Not reliably. Clinical registries and regulatory databases usually require active ingredient(s), dosage form, and target indication, not only a pack-level brand label.

3. What inputs are essential for market projection?
   Authorized regimen definition (actives, strength, route, duration), geography, indication scope, pricing/reimbursement category, and time horizon.

4. How do regimen differences affect competitiveness?
   Route and duration often determine clinical positioning, payer acceptance, and substitution patterns versus alternative schedules.

5. What would make the analysis actionable?
   A regimen-specific identifier tied to an authorized product (actives, strengths, pack contents) and a target market geography.

References

[1] Not applicable.