NCT06976424

Brief Summary

The study compares the effects of a cream alone and a combined effect of cream and laser for the treatment of excessive facial hairs in women .

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
recruiting

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

May 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

May 9, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

HirsuitismIPLEflornithine

Outcome Measures

Primary Outcomes (1)

  • Efficacy of treatment

    Efficacy of treatment is defined as complete clearance of excessive hairs assesed on the basis of 4- level scale ranging 0 to 3 after 3 months of administration of the treatment in both groups. Clear is grade 3 Marked improvement is grade2 Improved is grade1 No improvement is grade 0

    3 months

Study Arms (2)

GroupA

EXPERIMENTAL

This group is treated with combination of eflornithine cream and intense pulsed light for a period of three month.

Radiation: Instense pulsed lightDrug: Eflornithine Topical

Group B

EXPERIMENTAL

This group is treated with eflornithine cream twice daily only for a period of three month

Drug: Eflornithine Topical

Interventions

Eflornithine cream will be applied to the face of group B female patients

Also known as: Eflornithine cream
Group B

Intense pulse light will be applied to the face of patient of Group A on areas having increase hair. Patient will be called for a followup every month for next session.

GroupA

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll the female patients with excessive facial hairs were included in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gender (Female) Age between 18-45 Years Women with hirsutism as mentioned in the operational definition

You may not qualify if:

  • Pregnant women Women with severe acne Women with immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Khyber Teaching Hospital

Peshawar, Kpk, 25000, Pakistan

RECRUITING

Khyber Teaching Hospital

Peshawar, KPK, Pakistan

RECRUITING

Khyber Teachinng Hospital

Peshawar, KPK, Pakistan

RECRUITING

MeSH Terms

Conditions

Hirsutism

Interventions

Eflornithine

Condition Hierarchy (Ancestors)

Hair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrnithineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Diamino

Central Study Contacts

Umaima Nazar, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 16, 2025

Study Start

July 15, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Because the confedentiality of the patient would be breached.

Locations