NCT04379752

Brief Summary

Self applied cold plasma activated medium used for androgenetic alopecia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

April 30, 2020

Last Update Submit

November 20, 2023

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

  • Presence of detectable hair growth

    Presence of hair growth is observed clinically. Evaluation may include photo comparison, hair count, trichoscopy

    3 months and 6 months

Secondary Outcomes (1)

  • Adverse effects related to the treatment

    throughout study completeion, 6 months

Study Arms (1)

Cold-atmospeheric pressure plasma activated solution

EXPERIMENTAL

Treatment arm subjects receive the trial intervention

Device: Cold-atmospeheric pressure plasma activated aqueous-alcohol solution treatment

Interventions

Cold-atmospeheric pressure plasma activated aqueous-alcohol solution treatmentDEVICE

Cold plasma is generated and applied to carrier liquid. Subjects are provided with the liquid to apply to the treated area

Cold-atmospeheric pressure plasma activated solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of mild-to moderate androgenetic alopecia
  • ability of applying treatment regularly
  • ability to keep in-person follow-up appointments

You may not qualify if:

  • any inflammatory scalp condition
  • starting or discontinuing any hair loss treatments within 6 months of start date
  • allergy to any components of the carrier solution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Skin Center Dermatology Group

New City, New York, 10956, United States

Location

Related Publications (1)

  • Khan A, Malik S, Walia J, Fridman G, Fridman A, Friedman PC. Tolerability of Six Months Indirect Cold (Physical) Plasma Treatment of the Scalp for Hair Loss. J Drugs Dermatol. 2020 Dec 1;19(12):1177-1180. doi: 10.36849/JDD.2020.5186.

    PMID: 33346510DERIVED

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 7, 2020

Study Start

July 1, 2020

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)