Clinical Study to Evaluate Effect of Shampoo in Subjects... | NCT07433933

Studies
Clinical Study to Evaluate Effect of Shampoo in Subjects With Hair Loss.

NCT07433933

Sponsor

Lacer S.A.

Status

Completed

Last Update Posted

Feb 27, 2026Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Telogen Effluvium
Androgenetic Alopecia

Interventions

anti-hair loss shampoo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 12, 2025Actual

Primary Completion Date

Oct 16, 2025Actual

Completion Date

Oct 16, 2025Actual

First Submitted Date

Feb 19, 2026

First Submission Date that Met QC Criteria

Feb 19, 2026

First Posted Date

Feb 25, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2026

Last Update Posted Date

Feb 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about the effects of anti-hair loss shampoo in subjects over the age of 18 who use shampoo to treat their hair loss caused by telogen effluvium (TE) and androgenetic alopecia (AGA). The main question it aims to answer is:

• Does a shampoo use help to reduce the visible signs of hair loss related to TE and AGA?

Subjects will use the shampoo for 3 months and visit the clinic for the visits established by the protocol.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
anti-hair loss shampoo			Other: anti-hair loss shampoo

Name	Type	Description	Arm Group Labels	Other Names
anti-hair loss shampoo	Other	anti-hair loss shampoo use for 3 months	anti-hair loss shampoo

Measure	Description	Time Frame
Change in hair lenght and thickness		From baseline to the end of use at 3 months.

Measure	Description	Time Frame
Change in hair lenght and thickness at 1 month		Baseline and 1 month of use

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sex: Both (50% women; 50% men).
Age: 18-65 years.
Subjects with hair loss due to telogen effluvium or mild or incipient androgenic alopecia, in an 80/20 ratio.
Degree of androgenic alopecia: Ludwig scale score I-II for women and Hamilton-Norwood scale score III-II for men.
Telogen effluvium: Combing test.
Subjects with all hair types (oily, combination, sensitive, etc.).
Subjects with all scalp types (normal, sensitive, etc.).
Agree to participate voluntarily in the study and provide written informed consent.
Adequate level of understanding of the clinical study.
Good health (physical and mental).
Availability to attend visits to the research centres.
No application of any product to the experimental area on the first day of the trial.

Exclusion Criteria:

Individuals under 18 years of age.
Pregnant or breastfeeding women.
Injuries or infection in the test area.
History of allergies to cosmetic products.
Known allergies to product components.
Sensitivity to any product component.
Patients who have undergone recent surgery or treatments in the study area.
Cancer patients.
Volunteers currently taking antibiotics, antihistamines, corticosteroids, beta-blockers, retinoids, azelaic acid, or acne therapies, or whose treatment ended within 15 days prior to the start of the study. Participation in another clinical study.
Use of or having used cosmetic products and/or oral or topical treatments for hair loss for at least 6 months.
Hair cutting or dyeing during the study.
Health problems, to be assessed by the specialist, that may compromise adherence to the study protocol.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Clinic database

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Centro Médico Complutense Grupo Virtus		Alcalá de Henares	Madrid	28805	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Only summary of the results to support the publication will be shared. No complete study documents will shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases