Azelaic Acid for Central Centrifugal Cicatricial Alopecia

((CCCA) Trial)

Overseen By Victoria Palmer, MD, MSc

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Males

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether azelaic acid can help treat Central Centrifugal Cicatricial Alopecia (CCCA), a condition causing hair loss from the center of the scalp outward. Researchers aim to determine if azelaic acid, which may reduce inflammation, improves hair growth compared to a placebo. Participants will apply a topical treatment to their scalps daily for six months. Women diagnosed with CCCA and maintaining stable treatment routines for at least three months may be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how azelaic acid works in people, offering participants the opportunity to be among the first to explore its potential benefits.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable treatment without changes for at least three months, so you should not stop taking your current medications if they have been stable.

Is there any evidence suggesting that azelaic acid is likely to be safe for humans?

Research shows that azelaic acid is usually safe for use. It treats skin problems like acne and rosacea by reducing bacteria and swelling. In these cases, some people have experienced mild side effects such as itching, burning, or tingling at the application site. No major negative effects are commonly associated with its use.

Since this trial is in the early stages, the main goal is to ensure safety. Azelaic acid is already approved for other skin conditions, suggesting it is likely safe for skin use. However, this study specifically examines its effects on Central Centrifugal Cicatricial Alopecia (CCCA), a type of hair loss. Participants in the trial will help determine how well azelaic acid works for this new purpose, providing important safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Central Centrifugal Cicatricial Alopecia (CCCA), which often include corticosteroids or minoxidil that focus on reducing inflammation or promoting hair growth, azelaic acid offers a unique approach. Azelaic acid is a naturally occurring acid found in grains like wheat, and it is known for its anti-inflammatory and antimicrobial properties. Researchers are excited because it targets inflammation and abnormal keratinization, which are central to CCCA, potentially providing a dual benefit of reducing inflammation while also modulating skin cell production. This could make it a promising alternative or complement to existing therapies, especially for patients who may not respond well to current options.

What evidence suggests that azelaic acid might be an effective treatment for CCCA?

Research suggests that azelaic acid might help treat Central Centrifugal Cicatricial Alopecia (CCCA) by reducing inflammation, which can affect hair growth. It activates an enzyme called catalase, which protects cells and supports hair regrowth. In studies comparing azelaic acid with anthralin for a different type of hair loss, both treatments promoted similar hair regrowth. Although specific studies on CCCA are limited, these findings indicate that azelaic acid could potentially aid hair growth in CCCA by reducing inflammation. Participants in this trial will receive either azelaic acid treatment or continue with their current prescribed topical formulation as a control. ^{1 2 5 6 7}

Who Is on the Research Team?

Amy McMichael, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman aged 18 or older.

My current treatment has not changed for at least three months.

recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology

Exclusion Criteria

I am male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive azelaic acid or placebo treatment applied topically on the scalp once daily

6 months

Visits at baseline, months 2, 4, and 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Azelaic Acid

Trial Overview 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.

How Is the Trial Designed?

Group I: azelaic acid treatment Experimental Treatment 1 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 Group 1 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.

Azelaic Acid is already approved in United States, European Union for the following indications:

Approved in United States as Azelaic acid for:

• Acne
• Rosacea

Approved in European Union as Azelaic acid for:

• Acne
• Rosacea

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

A study involving ten teenagers with acne showed that topical application of 20% azelaic acid cream led to a significant reduction of about 26% in the number of comedos (blocked hair follicles) after four months of treatment.

The effectiveness of azelaic acid in reducing comedos may be linked to its ability to alter keratin production or exert anti-hormonal effects, supporting its use as a treatment for acne.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the anti-comedo effect of azelaic acid using the technique of horny layer biopsy and scanning electron microscopy]. Angius, AG., Barbareschi, M., Cattaneo, M., et al.[2014]

Azelaic acid cream (20%) is an effective topical treatment for mild to moderate acne, showing comparable efficacy to established therapies like tretinoin and benzoyl peroxide, based on vehicle-controlled studies.

It has a favorable safety profile, being non-teratogenic and well-tolerated, with no systemic side effects or resistance development in acne-causing bacteria, making it a suitable option for long-term maintenance therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of topical azelaic acid (20 percent cream): an overview of results from European clinical trials and experimental reports. Graupe, K., Cunliffe, WJ., Gollnick, HP., et al.[2014]

Azelaic acid has multiple beneficial effects, including anti-infective and anti-inflammatory properties, making it useful for treating various skin conditions.

It effectively inhibits follicular keratinization and reduces melanin production in the skin, supporting its use in managing disorders like acne and hyperpigmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Azelaic Acid: Evidence-based Update on Mechanism of Action and Clinical Application. Schulte, BC., Wu, W., Rosen, T.[2015]

Azelaic acid 15% gel (Finacea) is a new and effective first-line treatment for mild-to-moderate papulopustular rosacea, showing significant improvement in inflammatory lesions and redness over 15 weeks.

The main action of azelaic acid is its anti-inflammatory effect, which reduces reactive oxygen species, and it has a favorable safety profile with mostly mild side effects that rarely require stopping treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Azelaic acid 15% gel in the treatment of rosacea. Gollnick, H., Layton, A.[2019]

Azelaic acid 20% cream (AZELEX) is an effective anti-acne treatment, showing comparable efficacy to other common treatments like 0.05% tretinoin, 5% benzoyl peroxide, and 2% erythromycin.

One of the key advantages of azelaic acid is that it is less irritating than tretinoin and benzoyl peroxide, making it a gentler option for acne treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Azelaic acid 20% cream (AZELEX) and the medical management of acne vulgaris. Gibson, JR.[2016]

A combination of topical 20% azelaic acid cream and oral minocycline was found to be highly effective for treating severe inflammatory acne, achieving significant reductions in acne lesions, although it was slightly less effective than oral isotretinoin.

This combined treatment was better tolerated than isotretinoin, with fewer side effects, making it a safer alternative, especially for women of child-bearing potential, and it can also be used successfully as maintenance therapy to prevent acne recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of combined azelaic acid cream plus oral minocycline with oral isotretinoin in severe acne. Gollnick, HP., Graupe, K., Zaumseil, RP.[2014]

Topical azelaic acid (20% cream) is an effective and non-toxic treatment for all types of acne, showing comparable efficacy to other common acne treatments like tretinoin and benzoyl peroxide, based on extensive multi-centre clinical trials.

Azelaic acid is safe for long-term use, as it does not cause irritation, allergic reactions, or teratogenic effects, making it suitable for maintenance therapy and individual lesion treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Azelaic acid in the treatment of acne]. Nazzaro-Porro, M., Passi, S., Picardo, M., et al.[2014]

Azelaic acid is a naturally occurring compound that has shown significant potential as a therapeutic agent, particularly due to its ability to inhibit tyrosinase and other enzymes, as well as its antimicrobial effects against various microorganisms, including those causing acne.

Topical application of azelaic acid (20% cream) has demonstrated therapeutic benefits for different skin disorders, especially in treating various forms of acne and showing promise in managing conditions like melasma and cutaneous malignant melanoma, with minimal toxicity to normal cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Azelaic acid. Nazzaro-Porro, M.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05416333?cond=Central%20centrifugal%20cicatricial%20alopecia%20OR%20%22%22&aggFilters=status:not%20rec&viewType=Table&rank=2

Azelaic Acid as a Novel Treatment for Central Centrifugal ... In this study, the aim is to compare azelaic acid vs placebo since azelaic acid may increase anti-inflammatory effects that affect the hair growth cycle.

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/414438

Azelaic Acid as a Novel Treatment for Central Centrifugal ... The purpose of this pilot study is to determine if azelaic acid shows potential to be an effective treatment for Central Centrifugal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7595365/

The Use of Natural Ingredients in the Treatment of Alopecias ... The purpose of this review is to examine the literary evidence supporting the efficacy of natural ingredients for the treatment of CCCA. METHODS.

4. withpower.com withpower.com/trial/early-phase-1-central-centrifugal-cicatricial-alopecia-ccca-6-2022-a71e5

Azelaic Acid for Central Centrifugal Cicatricial Alopecia 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7508322/

Azelaic acid stimulates catalase activation and promotes ... Comparison of azelaic acid and anthralin for treatment of patchy alopecia areata showed that azelaic acid and anthralin gave similar results to hair regrowth ( ...

6. go.drugbank.com go.drugbank.com/drugs/DB00548

Azelaic acid: Uses, Interactions, Mechanism of Action Azelaic acid manifests its antibacterial effects by inhibiting the synthesis of cellular protein in anaerobic and aerobic bacteria.

7. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Azelaic-Acid

Azelaic Acid | C9H16O4 | CID 2266 - PubChem Slightly flammable to flammable in presence of heat. Spectrum Lab Products Inc.; Material Safety Data Sheet: Azelaic Acid (2007). ... NIST Mass Spectrometry Data ...