ALD-102 for Alopecia Areata

Recruiting at 4 trial locations

Overseen By Chief Scientific Officer

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Aldena Therapeutics

Must not be taking: Steroids, JAK inhibitors

Disqualifiers: Severe AA, Other alopecia, Cancer, others

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

24 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial requires participants to stop certain medications before joining. Specifically, you must not have used systemic treatments for inflammatory conditions, certain topical treatments, or specific medications affecting hair regrowth within 4 weeks before starting the trial. Additionally, you should not have used systemic or intralesional steroids within 8 weeks before the trial.

How does the ALD-102 drug for alopecia areata differ from other treatments?

The ALD-102 drug for alopecia areata is unique because it may involve a novel delivery method or formulation that is not specified in the available research, unlike traditional treatments like corticosteroid injections or excimer laser therapy, which have established mechanisms and delivery methods. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this first-in-human clinical trial is to learn if ALD-102 Solution is safe and well tolerated following injections in the scalp in subjects with alopecia areata. The study will also learn about the effect of ALD-102 on hair regrowth in treatment areas. The researchers will compare the effects of ALD-102 Solution (drug) to placebo (saline solution that contains no drug). Study participants will have two treatment areas selected on the scalp and will receive randomly ALD-102 Solution (drug) at one area and or placebo (saline solution) at the other area once every 4 weeks for a treatment period of 8 weeks.

Eligibility Criteria

This trial is for adults aged 18-55 with a BMI of 18.0-35.0 kg/m2, weighing at least 50 kg, who have alopecia areata (AA) with hair loss lasting between 6 months and 5 years but not more than that overall. Participants must have two similar AA patches on the scalp suitable for injections and agree to maintain their hairstyle and color throughout the study. Women must use effective contraception.

Inclusion Criteria

My BMI is between 18.0 and 35.0.

I weigh at least 50 kg.

I haven't had significant hair loss or regrowth in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALD-102 Solution or placebo injections in the scalp every 4 weeks for a treatment period of 8 weeks

8 weeks

Injections every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse effects and injection site reactions

16 weeks

Assessments every 4 weeks

Treatment Details

Interventions

• ALD-102 Solution

Trial Overview The trial tests ALD-102 Solution's safety and effectiveness in promoting hair regrowth compared to a placebo (saline solution). Subjects will receive injections in two areas of the scalp: one with ALD-102 and one with placebo every four weeks over an eight-week period.

Participant Groups

Group I: ALD-102 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Aldena Therapeutics

Lead Sponsor

Trials

1

Recruited

20+

References

1. United States pubmed.ncbi.nlm.nih.gov

Excimer laser: a module of the alopecia areata common protocol. [2016]

2. Australia pubmed.ncbi.nlm.nih.gov

Treatment of alopecia areata: An Australian expert consensus statement. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Combination of photodynamic therapy with 5-aminolaevulinic acid and microneedling in the treatment of alopecia areata resistant to conventional therapies: our experience with 41 patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Intradermal drug delivery by low-frequency sonophoresis (25 kHz). [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Successful Treatment of Alopecia Areata Patches with Triamcinolone Acetonide Using MMP®: Report of 2 Cases. [2021]