What side effects are associated with this type of intervention?

The 30% Ascorbic Acid in 95% Dimethylsulfoxide treatment may cause skin irritation, redness, and dryness due to the high concentration of ascorbic acid and the penetration-enhancing properties of dimethylsulfoxide. On the other hand, 5% Imiquimod Cream, an immune response modifier, is known to cause local skin reactions such as redness, swelling, itching, and burning. Systemic side effects like flu-like symptoms (fever, fatigue, muscle aches) can also occur. Both treatments aim to target abnormal skin cells but can lead to significant local skin irritation.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-melanoma Skin Cancer, including topical agents like 5% Imiquimod Cream, which is an immune response modifier used to treat superficial basal cell carcinoma and actinic keratosis. Another approved treatment is 5-fluorouracil, a topical chemotherapeutic agent used for actinic keratosis and superficial basal cell carcinoma. Photodynamic therapy (PDT) using agents like aminolevulinic acid (ALA) is also FDA-approved for actinic keratosis and certain types of basal cell carcinoma. These treatments focus on enhancing the immune response, direct cytotoxic effects, or utilizing light-activated compounds to target cancerous cells.

What other types of research exist?

Promising novel alternatives for non-melanoma skin cancer treatment in 2024 include: 1) Vismodegib and Sonidegib, oral small-molecule inhibitors of the Smoothened (SMO) pathway, which have shown efficacy in reducing tumor burden and slowing the rate of BCC development. 2) Photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA) or methyl aminolevulinate (MAL), which has been effective for both BCC and SCC. 3) Daylight photodynamic therapy, which offers a nearly painless and convenient alternative to conventional PDT for actinic keratosis, a precursor to SCC.

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Ascorbic Acid for Skin Cancer

Q: What is the mechanism of action of this treatment?

The 30% Ascorbic Acid in 95% Dimethylsulfoxide works as an antioxidant and penetration enhancer. Ascorbic acid (Vitamin C) helps to neutralize free radicals, reducing oxidative stress that can lead to cancer cell growth, while dimethylsulfoxide (DMSO) enhances the penetration of ascorbic acid into the skin, increasing its efficacy. On the other hand, 5% Imiquimod Cream is an immune response modifier that stimulates the body's immune system to produce cytokines, particularly interferon-alpha, which helps to attack and destroy cancer cells. These mechanisms are crucial for NMSC patients as they offer non-invasive treatment options that can effectively target and eliminate cancer cells while minimizing damage to surrounding healthy tissue.

Phase < 1

Recruiting

Research Sponsored by Center for Biomedical Research, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of biopsy proven squamous cell cancer of the skin

Be older than 18 years old

Must not have

Previous history of malignancy

Diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a vitamin C solution and an approved cream for treating a specific type of skin cancer in adults. The vitamin C solution aims to kill cancer cells and reduce inflammation, while the cream boosts the immune system to fight cancer. Vitamin C has been studied for its various health benefits.

Who is the study for?

This trial is for adults with biopsy-proven squamous cell skin cancer. It's not suitable for those who've had other cancers, have diabetes, or are immunocompromised.

What is being tested?

The study tests a topical solution of 30% ascorbic acid in DMSO against a standard treatment (5% imiquimod cream) to see which is better at clearing up squamous cell carcinomas of the skin over an 8-week period.

What are the potential side effects?

Potential side effects may include skin irritation, redness, and discomfort where the ascorbic acid solution or imiquimod cream is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with squamous cell skin cancer through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had cancer before.

Select...

I have diabetes.

Select...

My immune system is weak.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lesion Resolution

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 30% Ascorbic Acid in DMSOExperimental Treatment1 Intervention

Topical application twice daily of 300ul 30% (w/v) solution of ascorbic acid in DMSO

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The 30% Ascorbic Acid in 95% Dimethylsulfoxide works as an antioxidant and penetration enhancer. Ascorbic acid (Vitamin C) helps to neutralize free radicals, reducing oxidative stress that can lead to cancer cell growth, while dimethylsulfoxide (DMSO) enhances the penetration of ascorbic acid into the skin, increasing its efficacy. On the other hand, 5% Imiquimod Cream is an immune response modifier that stimulates the body's immune system to produce cytokines, particularly interferon-alpha, which helps to attack and destroy cancer cells. These mechanisms are crucial for NMSC patients as they offer non-invasive treatment options that can effectively target and eliminate cancer cells while minimizing damage to surrounding healthy tissue.

Therapeutic effect of Imiquimod enhanced ALA-PDT on cutaneous squamous cell carcinoma.Therapy of cutaneous squamous cell carcinoma in two retirement home residents.