What side effects are associated with this type of intervention?

Common treatments for Central Centrifugal Cicatricial Alopecia (CCCA) with anti-inflammatory effects include corticosteroids and immunosuppressive agents. Corticosteroids, often used topically or intralesionally, can cause skin thinning, irritation, and potential systemic effects like adrenal suppression with prolonged use. Immunosuppressive agents, such as cyclosporine, may lead to serious side effects including increased risk of infections, hypertension, and kidney dysfunction. Azelaic acid, being studied for its anti-inflammatory properties, may offer a safer profile, but further studies are needed to confirm its efficacy and safety.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Central Centrifugal Cicatricial Alopecia (CCCA) mentioned in the provided context. However, azelaic acid is being studied for its potential anti-inflammatory effects that may positively impact the hair growth cycle in CCCA. Other treatments with anti-inflammatory properties, such as corticosteroids, are commonly used off-label to manage inflammatory scalp conditions, but specific FDA approvals for CCCA are not detailed.

What other types of research exist?

Promising novel alternatives to Azelaic Acid for Central Centrifugal Cicatricial Alopecia (CCCA) include minoxidil, 3,4,5-tri-O-caffeoylquinic acid (TCQA), and Cistanche tubulosa and Laminaria japonica extracts. These treatments have shown potential in promoting hair growth and have anti-inflammatory properties.

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Azelaic Acid for Central Centrifugal Cicatricial Alopecia ((CCCA) Trial)

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

The most common treatments for Central Centrifugal Cicatricial Alopecia (CCCA) often focus on reducing inflammation to prevent scarring and permanent hair loss. Azelaic acid, for example, has anti-inflammatory properties that may positively affect the hair growth cycle by reducing follicular inflammation. Other treatments like corticosteroids and immunosuppressants also work by dampening the immune response, thereby reducing inflammation and preventing further damage to hair follicles. This is crucial for CCCA patients as controlling inflammation can help preserve existing hair and potentially stimulate regrowth, improving both clinical outcomes and quality of life.

Phase < 1

Recruiting

Led By Amy J McMichael, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

biopsy-proven and /or clinical diagnosis of CCCA Stage II-IV

Biopsy-proven and/or clinical diagnosis of CCCA Stage II-IV

Must not have

Males

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 2, 4, and 6

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing azelaic acid to see if it can help people with Central Centrifugal Cicatricial Alopecia (CCCA), a challenging hair loss condition. Azelaic acid might reduce inflammation, which could help hair grow back. The study aims to determine the effectiveness of azelaic acid. Azelaic acid has been used effectively for treating acne and rosacea, and it has shown potential in promoting hair growth when combined with minoxidil.

Who is the study for?

This trial is for women over 18 with a confirmed diagnosis of Central Centrifugal Cicatricial Alopecia (CCCA) stages II-IV. Participants must have been on a stable treatment plan for at least three months without changes, and they are recruited from outpatient dermatology clinics.

What is being tested?

The study tests azelaic acid's effectiveness against CCCA compared to a placebo. Azelaic acid is thought to reduce inflammation that can interfere with hair growth. This pilot study aims to see if it could be an effective treatment option.

What are the potential side effects?

While the specific side effects in this trial aren't listed, azelaic acid generally may cause skin irritation, burning sensation, itching or redness where applied.

Eligibility Criteria

Inclusion Criteria

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

Select...

My condition is diagnosed as Stage II-IV CCCA.

Select...

My condition is diagnosed as Stage II-IV CCCA.

Exclusion Criteria

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

Select...

I am male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 2, 4, and 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 2, 4, and 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 2, 4, and 6 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Amount of hair loss regression

Secondary study objectives

Amount of alleviation of signs and symptoms of disease

Amount of hair regrowth

Dermatology Life Quality Index (DLQI)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: azelaic acid treatmentExperimental Treatment1 Intervention

Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.

Group II: control (no additional treatment)Placebo Group1 Intervention

Subjects will continue to use their current primary provider prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months.

0 / 3Eligibility 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 most common treatments for Central Centrifugal Cicatricial Alopecia (CCCA) often focus on reducing inflammation to prevent scarring and permanent hair loss. Azelaic acid, for example, has anti-inflammatory properties that may positively affect the hair growth cycle by reducing follicular inflammation. Other treatments like corticosteroids and immunosuppressants also work by dampening the immune response, thereby reducing inflammation and preventing further damage to hair follicles. This is crucial for CCCA patients as controlling inflammation can help preserve existing hair and potentially stimulate regrowth, improving both clinical outcomes and quality of life.