Health TrialsbyHealthPanel

Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)

ConditionsAndrogenic AlopeciaAlopeciaBaldness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAcorn Biolabs Inc.

About this trial

(SINGLE SITE Study) The purpose of this clinical trial is to evaluate the safety and efficacy of the use of an autologous hair follicle derived secretome for androgenous alopecia. The secretome will be injected into the scalp at baseline, and days 30, 90, 180, 270 and 365.

Hair growth will be quantitatively measured for density and thickness. PROs will also be collected from participants. This study will be run at a SINGLE SITE.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

SUBJECTS MUST BE ON A STABLE COURSE OF MINOXIDIL (ORAL OR TOPICAL) AND/OR 5-ALPHA REDUCTASE INHIBITORS. THEY MUST HAVE BEEN ON THE SAME 5-ALPHA REDUCTASE INHIBITOR FOR ≥12 MONTHS PRIOR TO BASELINE.

FEMALE SUBJECTS MUST NOT BE ON HAIR GROWTH MEDICATIONS OR TOPICALS FOR ≥6 MONTHS PRIOR TO BASELINE.

TESTOSTERONE REPLACEMENT THERAPY (TRT) IN ANY FORM (E.G. DEPO-, INJECTABLE, TOPICAL, PATCHES, NASAL GEL, ORAL, PELLET ETC.) IS ALLOWED AS LONG AS SUBJECT HAS BEEN ON A STABLE COURSE (IN THE OPINION OF THE INVESTIGATOR) OF TRT FOR ≥12 MONTHS.

Biological sex: Male and Female (up to n=20 males and up to n=10 females will be in each arm for a total of up to n=40 males and up to n=20 females)

Disqualifiers

Subjects with clinical diagnosis of alopecia areata or other non-androgenic forms of alopecia.

Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp

Scalp infection

Severe active systemic infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous Hair Follicle-Derived Secretome

    Other intervention

    Hair follicles are plucked, cultured and the product is the resulting cell secretions (secretome) collected from the conditioned media.

  • Placebo Control

    Other intervention

    The same saline used for diluting the active treatment in will be used as a control.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Active-SecretomeActive comparator 1 intervention
Group B: Placebo ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Target Area Hair Counts (TAHC)

Non-vellus TAHC is the number of non-vellus (terminal) hairs within 1 cm² scalp

Time frame
180 Days after Baseline
2

Safety

Incidence rates of treatment-related adverse events compared between the active and placebo arm

Time frame
180 days from Baseline

Secondary outcomes

1

Mean Total Hair Density (vellus and non-vellus/terminal)

Mean Total Hair Density (vellus and non-vellus/terminal): measured by Trichoscan device

Time frame
30, 90, 270 and 365 days
2

Patient Satisfaction

Patient satisfaction collected using a 5 point Likert scale

Time frame
30, 90, 270 and 365 days
3

Hair thickness improvement

Hair thickness improvement measured by Trichoscan device

Time frame
30, 90, 180, 270 and 365 days
4

Patient Global Impression of Change (PGIC)

Patient rated improvement in alopecia based on comparison of Baseline to follow-up time point

Time frame
180 and 365 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Acorn Biolabs Inc.

Lead sponsor

Source ClinicalTrials.gov
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