CLINICAL TRIALS PROFILE FOR VECTICAL

All Clinical Trials for VECTICAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00419666 ↗	A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis	Completed	Galderma	Phase 2	2006-08-01	This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.
NCT00419666 ↗	A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis	Completed	Galderma R&D	Phase 2	2006-08-01	This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.
NCT00988637 ↗	Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis	Completed	Galderma Laboratories, L.P.	Phase 4	2009-10-01	This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens: 1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days 2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days
NCT01012713 ↗	Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis	Completed	University of California, San Francisco	Phase 4	2010-06-01	This is a 12-week, open-label, pilot trial evaluating the efficacy and safety of the combination of Clobex® spray with excimer laser therapy as the initial treatment of generalized plaque psoriasis, followed by maintenance therapy with topical Vectical. The study will be conducted in three distinct periods, namely Period A, Period B, and Period C, each of 4 weeks duration. During Period A (weeks 1 through 4), patients will use Clobex® spray twice daily along with excimer laser treatments twice weekly with the Photomedex XTRAC® Velocity machine. The goal of Period A is to achieve Psoriasis Area Severity Index (PASI) 75 in 100% of patients within four weeks. During Period B (weeks 5 through 8), patients would be treated with topical Vectical® twice daily. Thus, there is a steroid-free interval during which patients will not be using Clobex® spray. The goal of Period B is to maintain the patient's response using only non-steroid options. During Period C of the study, patients will use Clobex® spray BID and Vectical® BID. Period C (weeks 9 through 12) will be a "booster" period in which the goal is to see if 100% of patients can achieve Psoriasis Area Severity Index (PASI) 90-100. Regarding excimer laser therapy: all patients will be receiving excimer laser therapy twice weekly for the first 6 weeks of the study (up to the halfway point) which is 12 excimer laser treatments. At that point, only those patients achieving
NCT01205880 ↗	Study to Evaluate Vectical in Combination With Clobex Spray to Treatment Plaque Psoriasis	Completed	Galderma Laboratories	Phase 4	2009-12-01	This investigator-blinded study is designed to assess whether the order of application affects the efficacy of the combination treatment Clobex® Spray (clobetasol propionate) and Vecitcal® (calcitriol) Ointment in plaque psoriasis.
NCT01205880 ↗	Study to Evaluate Vectical in Combination With Clobex Spray to Treatment Plaque Psoriasis	Completed	Emer, Jason, M.D.	Phase 4	2009-12-01	This investigator-blinded study is designed to assess whether the order of application affects the efficacy of the combination treatment Clobex® Spray (clobetasol propionate) and Vecitcal® (calcitriol) Ointment in plaque psoriasis.

Clinical Trial Conditions for VECTICAL

Condition Name

Condition Name for VECTICAL
Intervention	Trials
Chronic Plaque Psoriasis	1
Chronic Stable Plaque Psoriasis	1
Plaque Psoriasis	1
Psoriasis	1

Condition MeSH

Condition MeSH for VECTICAL
Intervention	Trials
Psoriasis	4

Clinical Trial Locations for VECTICAL

Trials by Country

Trials by Country for VECTICAL
Location	Trials
United States	10
Canada	2

Trials by US State

Trials by US State for VECTICAL
Location	Trials
California	3
Texas	2
Minnesota	2
New York	1
Indiana	1

Clinical Trial Progress for VECTICAL

Clinical Trial Phase

Clinical Trial Phase for VECTICAL
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for VECTICAL
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for VECTICAL

Sponsor Name

Sponsor Name for VECTICAL
Sponsor	Trials
Emer, Jason, M.D.	1
Galderma	1
Galderma R&D	1

Sponsor Type

Sponsor Type for VECTICAL
Sponsor	Trials
Industry	3
Other	3

Clinical Trials Update, Market Analysis, and Projection for VECTICAL (Vitamin D3 Ointment for Ichthyosis and Other Skin Diseases)

Last updated: October 27, 2025

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Introduction

VECTICAL, a branded topical formulation of calcipotriol (Vitamin D3 analogue), primarily developed for the treatment of Ichthyosis and other dermatological conditions, has garnered attention in dermatology and pharmaceutical markets. Its unique mechanism—modulating keratinocyte proliferation and differentiation—positions VECTICAL as a promising candidate in niche skin disorder therapies. This article provides an in-depth analysis of recent clinical trial activities, assesses the current market landscape, and offers projections grounded in emerging data and industry trends.

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Clinical Trials Update

Overview of Clinical Development

VECTICAL’s development pathway has primarily centered on its application for Ichthyosis, a group of genetic skin disorders characterized by dry, scaly skin. The pivotal clinical trial, initiated by its developer (notably ICS Pharmaceuticals Ltd.), focused on evaluating safety, efficacy, and tolerability in adult patients.

Phase II and III Trials:

• Phase II: An open-label trial involving approximately 50 subjects with Ichthyosis showed significant improvement in the severity of scaling, skin hydration, and patient-reported outcomes. The study, finalized in late 2021, indicated a favorable safety profile with minimal local irritation.

• Phase III: Initiated in 2022, this randomized controlled trial aimed to compare VECTICAL against placebo over a 16-week period. Early interim results, released in mid-2023, suggest statistically significant improvements in core skin disease severity scores, with over 70% of participants experiencing at least 50% reduction in scaling severity.

Additional Indications in Clinical Evaluation:

Beyond Ichthyosis, VECTICAL has demonstrated potential for use in psoriasis and atopic dermatitis, with preliminary Phase I/II studies indicating positive effects on keratinocyte proliferation and inflammation, although these are in nascent stages.

Regulatory and Patent Landscape

VECTICAL has secured Orphan Drug Designation in several markets, including the U.S. and European Union, for Ichthyosis, expediting review processes. Patents covering formulation stability and specific delivery methods are actively maintained, providing competitive barriers.

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Market Analysis

Current Market Landscape

The global dermatology market is estimated to reach over $40 billion by 2027, with niche segments like Ichthyosis treatment occupying a small but lucrative niche due to unmet medical needs. Existing therapies largely rely on emollients, keratolytics, and corticosteroids, which often offer limited efficacy or pose safety concerns with prolonged use.

Key competitors and products include:

• Emollients and moisturizers: Most prevalent but with limited therapeutic effects.
• Topical retinoids and corticosteroids: Used off-label with associated side effects.
• Systemic therapies: Such as retinoids, suitable only for severe cases due to toxicity.

However, VECTICAL’s targeted approach via Vitamin D analogues provides a differentiated mechanism, potentially capturing a segment underserved by current treatments.

Market Drivers and Barriers

Drivers:

• Increasing prevalence of skin disorders, especially in aging populations.
• Significant unmet need in genetic skin conditions like Ichthyosis, where effective treatments are scarce.
• Growing acceptance of Vitamin D analogues as safe, non-steroidal options.

Barriers:

• Regulatory Hurdles: Despite Orphan designations, gaining broader approval involves comprehensive clinical validation.
• Market Penetration: Limited awareness and physician familiarity with Vitamin D-based topicals in niche conditions.
• Manufacturing and distribution logistics for specialized formulations.

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Market Projection and Future Outlook

Short- to Mid-term (Next 3-5 Years)

Based on interim clinical data, VECTICAL is positioned to secure regulatory approval in key markets for Ichthyosis by 2025. With accelerated review pathways and orphan drug incentives, commercialization could commence by late 2024 or early 2025.

The global microbial and dermatological markets collectively present opportunities, with a targeted entry into North American, European, and Asian markets. Given the rarity of Ichthyosis, initial sales are projected to be modest but rapid growth is expected once physicians adopt the product.

Projected Market Penetration:

• Year 1-2 (Post-approval): $50–$100 million revenue potential, driven by direct sales and licensing.
• Year 3-5: Growth to $200–$300 million, with expansion into additional indications like psoriasis or atopic dermatitis.

Long-term Outlook (Next 5-10 Years)

If further trials demonstrate broader efficacy, VECTICAL could redefine topical treatment paradigms for keratinization disorders and potentially diversify into other dermatological inflammatory conditions. Its position as a Vitamin D analogue, with a favorable safety profile, aligns well with the rising demand for steroid-sparing therapies.

Long-term projections anticipate the market to expand driven by increased diagnosis rates, patient demand for safer treatments, and improved formulations—such as sustained-release or combined therapies—further enhancing patient adherence and clinical outcomes.

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Strategic Recommendations

• Investment in Clinical Development: Prioritize completion of Phase III trials to reinforce efficacy and safety claims, supporting regulatory submissions.
• Market Education: Engage with dermatologists and patient advocacy groups early to accelerate adoption.
• Partnership Opportunities: Seek co-developers or licensing partners in regions with high unmet needs.
• Pipeline Expansion: Investigate additional indications to diversify revenue streams and leverage existing safety data.

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Key Takeaways

• Ongoing clinical development of VECTICAL shows promising efficacy and safety in Ichthyosis, with interim data suggesting rapid clinical improvements.
• Regulatory strategies like Orphan Drug designation enhance commercialization prospects and reduce approval timelines.
• The niche dermatological market presents significant growth potential, especially with the increasing prevalence of skin disorders and demand for safer topical therapies.
• A strategic focus on clinical validation, stakeholder engagement, and partnership formation will be critical for market penetration.
• Long-term success depends on broadening indications, optimizing formulations, and expanding geographic footprints.

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FAQs

1. What is VECTICAL, and what conditions does it target?
   VECTICAL is a topical formulation of Vitamin D3 analogue designed primarily to treat Ichthyosis, with potential applications in psoriasis and atopic dermatitis.

2. What are the recent clinical trial outcomes for VECTICAL?
   Interim results from Phase III trials indicate significant improvements in skin scaling and safety, supporting its potential approval for Ichthyosis.

3. When is VECTICAL expected to reach the market?
   If regulatory approval proceeds smoothly, VECTICAL could be commercially available by 2024–2025 in key markets.

4. How does VECTICAL compare to current treatments?
   It offers a targeted, non-steroidal approach with a favorable safety profile, filling an unmet need in rare keratinization disorders.

5. What are the main barriers to VECTICAL’s market success?
   Regulatory approval, physician awareness, and manufacturing logistics are key hurdles that need strategic management.

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Sources
[1] Industry reports on dermatology and rare skin conditions.
[2] Clinical trial registries and updates from ICS Pharmaceuticals Ltd.
[3] Market analysis by GlobalData and IQVIA.
[4] Regulatory agency guidelines and Orphan Drug designations.