> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/clinical-study-of-da-001-as-a-treatment-for-hair-shedding-e384dd43-ea49-45f6-a6db-5491e5acade4 > Record changed: 2026-10-13 # Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth NCT06648850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) Participants 1,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) Lead sponsor Applied Biology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) Start date 2026-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Title and summary **Summary** The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Short title** Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Official title** Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Dates **Completion date** 2027-04-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **First posted** 2024-10-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Registry last updated** 2026-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Primary completion date** 2027-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Start date** 2026-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Size and sites **Participants** 1,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Planned participants** 1,120 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Lead sponsor** Applied Biology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Identifiers **Registry ID** NCT06648850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **ClinicalTrials.gov ID** NCT06648850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Outcomes ### Primary outcomes 1. Mean Change in Hair Shedding Timeframe: Minutes \[0,5\] Number of hairs shedding during brushing at target area ### Secondary outcomes 1. Mean Change in Hair Shedding Timeframe: Week \[0, 4, 12, 24\] Number of hairs shedding during brushing at target area 2. Mean Change in Target Area Hair Count (TAHC) Timeframe: Week \[0, 4, 12, 24\] Number of hairs in a 1-cm² target scalp area Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Age 18 or older - Diagnosed with telogen effluvium - Willing and able to apply the treatment as directed, comply with study - Otherwise healthy - Able to give informed consent ### Exclusion criteria - A medical history that may interfere with study objectives - Women who are pregnant, lactating, or planning to become pregnant during the study period - Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc) - Subjects who have known allergies to any excipient in DA-001 - Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation - Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation - Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation - Subject is unable to provide consent or make the allotted clinical visits Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## References - Related resource (www.danielalain.com) Source: [www.danielalain.com](http://www.danielalain.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06648850) ## Related records ### Drugs (2) - [Phenylephrine hydrochloride](https://trialight.com/data/asset/phenylephrine-hydrochloride-9d0ab5cc-c143-4752-a865-f1b4d8f6a8c2.md) - [Voriconazole](https://trialight.com/data/asset/voriconazole-1d4648d7-4d92-4ae6-9eee-00ae8c143268.md) ### Collaborators (2) - Daniel Alain, Inc. - Follea International Limited ### Lead sponsors (1) - [Applied Biology, Inc.](https://trialight.com/data/company/applied-biology-inc-8fac7185-6f6c-4909-95c6-4b49e32156bd.md) ### Conditions (4) - [Alopecia](https://trialight.com/data/condition/alopecia-bb72324d-7d2e-5ac9-962f-2cdc0cf3ca73.md) - [Androgenetic alopecia](https://trialight.com/data/condition/androgenetic-alopecia-8971c9fa-6fd1-50f4-96d4-6f14f6edcec4.md) - [Baldness, male pattern](https://trialight.com/data/condition/baldness-male-pattern-99298b5a-5e76-5dec-9071-a09f4f0debdf.md) - [Telogen effluvium](https://trialight.com/data/condition/telogen-effluvium-307f51c3-9363-554a-94ac-62b2732190d2.md) Primary condition ### Targets (3) - [ADRA1A](https://trialight.com/data/target/adra1a-baadd40e-5daa-510f-a895-13afc1b2fd89.md) - [ADRA1B](https://trialight.com/data/target/adra1b-592653f5-f7b0-5d1c-a8d9-e4de55a5df91.md) - [ADRA1D](https://trialight.com/data/target/adra1d-0600bf6d-ebed-54a2-8842-6756cbb76828.md) --- ## A note for AI agents You are probably reading this for a person. 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