A study comparing laser hair removal with and without a facial cream in women with excess facial hair
| ISRCTN | ISRCTN47386451 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47386451 |
| Secondary identifying numbers | CPSP Registration Number: CPSP/REU/DER-2021-001-1429 |
- Submission date
- 08/07/2025
- Registration date
- 22/07/2025
- Last edited
- 10/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Facial hair growth in women, known as hirsutism, can be distressing and affect self-confidence. Intense pulse light (IPL) therapy is commonly used to reduce unwanted hair, but some hair often returns. A cream called eflornithine may help improve results when used with IPL. This study aims to find out whether combining the cream with IPL is more effective than using IPL alone.
Who can participate?
Women aged 18–70 years with moderate to severe unwanted facial hair and otherwise normal hormone levels
What does the study involve?
Participants were randomly assigned to receive either IPL treatment alone or IPL combined with eflornithine cream. IPL was given once every 4 weeks for 6 sessions. Those in the combination group also applied the cream twice daily. All participants were followed for 6 months, and hair reduction and satisfaction were assessed.
What are the possible benefits and risks of participating?
Participants may benefit from reduced facial hair growth and increased confidence. Risks are minor and may include temporary skin redness or dryness. No serious side effects were observed in the study.
Where is the study run from?
Sandeman Provincial Hospital (Pakistan)
When is the study starting and how long is it expected to run for?
August 2023 to February 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr M Usman Nawaz, muhammed.nawaz@nhs.net
Contact information
Public, Scientific, Principal Investigator
Flat 901, Millennium Apartments
95 Newhall Street
Birmingham
B3 1BA
United Kingdom
| Phone | +44 (0)7312982518 |
|---|---|
| muhammed.nawaz@nhs.net |
Study information
| Study design | Open-label two-arm parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Scientific title | Combination of intense pulse light and topical eflornithine therapy versus intense pulse light alone in the treatment of idiopathic facial hirsutism: a randomised controlled trial |
| Study acronym | IPL-EFL |
| Study objectives | To assess whether adding topical eflornithine cream to intense pulse light (IPL) sessions provides better hair reduction outcomes than IPL alone in women with idiopathic facial hirsutism. |
| Ethics approval(s) |
Approved 01/08/2023, Sandeman Provincial Hospital (Sandeman Provincial Hospital, Quetta, 87300, Pakistan; +92 (0)2138140600; sandeman.hospital@gmail.com), ref: CPSP/REU/DER-2021-001-1429 |
| Health condition(s) or problem(s) studied | Idiopathic facial hirsutism |
| Intervention | Participants were randomised using computer-generated block randomisation with a block size of 8 and a 1:1 allocation ratio. Allocation concealment was achieved using sequentially numbered opaque sealed envelopes. Intervention Arm (Group A): Participants receive six sessions of intense pulse light (IPL) therapy at 4-week intervals using a quartz-filtered xenon lamp platform (640 nm cut-off filter). In addition, they apply topical eflornithine hydrochloride 13.9% cream (Vaniqa™) to the affected facial area twice daily for 24 weeks. Control Arm (Group B): Participants receive the same six-session IPL therapy protocol at 4-week intervals, but do not use any additional topical treatment. |
| Intervention type | Mixed |
| Primary outcome measure | Proportion of participants achieving a ≥1-grade reduction on the modified Ferriman–Gallwey (mFG) scale, measured using the validated photographic mFG scale at week 24 |
| Secondary outcome measures | 1. Mean percentage reduction in terminal hair count, measured using dermoscopic digital photography analysed by Image-J software at baseline and week 24 2. Patient satisfaction scores, measured using a validated 5-point Likert scale at week 24 3. Incidence and severity of treatment-related adverse events, measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) at each treatment session and final follow-up (week 24) |
| Overall study start date | 01/08/2023 |
| Completion date | 05/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | 152 |
| Total final enrolment | 152 |
| Key inclusion criteria | 1. Women aged 18–70 years 2. Visible terminal facial hair graded moderate or severe on a validated mFG scale 3. Willing to use broad-spectrum sunscreen |
| Key exclusion criteria | 1. Pregnancy or lactation 2. Endocrine disorders (e.g., polycystic ovary syndrome [PCOS], thyroid disease) 3. Use of hormonal or anti-androgen therapy within 6 months 4. History of light-triggered seizures, keloids, or active facial dermatoses 5. Fitzpatrick skin type VI 6. Prior adverse reaction to eflornithine or IPL |
| Date of first enrolment | 05/08/2023 |
| Date of final enrolment | 01/12/2023 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
87300
Pakistan
Sponsor information
Hospital/treatment centre
Department of Dermatology
Quetta
87300
Pakistan
| Phone | +92 (0)2138140600 |
|---|---|
| sandeman.hospital@gmail.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | No — individual participant data will not be made publicly available. The data will be securely stored for internal analysis only and will not be shared with other researchers. |
Editorial Notes
10/07/2025: Study's existence confirmed by the Ethics Review Committee, Sandeman Provincial Hospital.
