Excessive HairinessAntheliaNCT06655129
Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
A study testing intense pulsed light in people with Excessive Hairiness and Vascular Lesion, run by Eurofeedback at 5 sites in France.
Trial summary
The first IPL device obtained United States Food and Drug Administration (FDA) clearance in 1995 for treatment of lower extremity telangiectasias. Since then, its favorable cost and versatility in contrast to many singlespectrum lasers, has led to its rapid proliferation and use in a number of different clinical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Excessive Hairiness, Vascular Lesion, Pigmented Lesions
- What is being tested?
- intense pulsed light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesFrance
- Study dates
- 20 Jan 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult men or women
- Excessive Hairiness:
- Patient with unwanted hair on the body (legs, arms, bikini line, or axilla)
- Patient over 18 years.
- Patients with Fitzpatrick skin types from I to V.
- Women were required to be post-menopausal, surgically sterilized, or under a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, or barrier methods with spermicide or abstinence) during the study time period.
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- Vascular lesions:
- Patients over 18 years.
- Patients with Fitzpatrick skin types from I to IV.
- Patients with varicosities and Rosacea on the face or upper and lower limbs.
- Pigmented lesions:
- Patients over 18 years.
- Patients with solar lentigines on their cheeks, back, hands, arm and leg (> 3 mm).
- Patient with Fitzpatrick skin type from I to IV.
- Acne:
- Patients over 18 years
- Patients with Fitzpatrick skin types from I to IV.
- Patients with facial acne vulgaris on face.
- Willing to sun protect treated area for the duration of enrollment in the study and 4 weeks after treatment.
Who cannot join
- Patients with history of malignant lesions or pre-malignant lesions, scarring, or infection in the area to be treated History of keloidal or hypertrophic scarring
- Patients with a known photosensitivity
- Pregnancy women
- Patient with diabetes mellitus suntan in the area to be treated
- Use of photo-sensitizing products for 7 days before treatment (selftanning lotions, activators, self-tanning shower gel, etc.)
- Exposure to the sun or UV rays at least 4 weeks before the treatment and 1 week afterwards
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- Zones with uncovered tattoos, suspect spots or skin diseases (including spots, inflammation, beauty spots, tumors or melanomas, psoriasis, herpes...)
- Use of medication that induces anticoagulative medication or thromboembolic condition
- Patients with pacemaker or internal defibrillator
- Patients that used of NSAIDS two weeks prior to or 2 weeks following the treatment
- Epileptic patients
- Additional criteria for excessive hair: Patients that use waxing or other methods of photo epilation within 1 month prior to treatment.
- Additional criteria for acne: Patients currently under oral antibiotic or oral therapy for acne.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CH Auxerre
Auxerre
- Recruiting
HIACT Brest
Brest
- Recruiting
Centre TrialAzur
Nice
- Not yet recruiting
CH Périgueux
Périgueux
- Recruiting
CHU POitiers
Poitiers
About this study
Official title: Post Market Clinical Study of an Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
The first IPL device obtained United States Food and Drug Administration (FDA) clearance in 1995 for treatment of lower extremity telangiectasias. Since then, its favorable cost and versatility in contrast to many singlespectrum lasers, has led to its rapid proliferation and use in a number of different clinical settings. As described in the literature, ANTHÉLIA medical device is intended to treat skin disorders:
- Excessive Hairiness (Hirsutism, Hypertrichosis...)
- Vascular lesions (Rosacea….)
- Pigmented lesions (Lentigo et melasma)
- Acne vulgaris
- Conditions
- Excessive Hairiness, Vascular Lesion, Pigmented Lesions, Acne Vulgaris
- Being tested
- intense pulsed light
- Medical subject headings
- Hirsutism, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intense pulsed lightDevice
intense pulsed light (IPL) using the Medical Device Anthelia
| Study group | Role | What they receive |
|---|---|---|
| Intense Pulsed Light Treatment | Experimental | Patients will be treated at different visits, and according to the IFU, with the Anthelia Medical Device (Intense Pulsed Light). Receives: Device: intense pulsed light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacity for Excessive Hairiness:
Excessive Hairiness by hair counting a 4cm2 surface (To demonstrate a hair reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as six sessions spaced by 12 weeks)
Measured: up to 18 months
Efficacity for Vascular lesions and Pigmented lesions
Vascular lesions: To demonstrate a reduction of 70% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks.
To demonstrate a clinical improvement of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks.
Pigmented Lesions: To demonstrate a reduction of 60% between the average score of the treated aera before and after a cycle of treatment defined as three sessions spaced by 10 weeks.
Measured: up to 4 months
Efficacity for Acne vulgaris
measuring the diameter of each pimple in a treated area (before and after), To demonstrate a lesion reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 2 weeks.
Measured: up to 4 months
Secondary outcomes (3)
For all patients decrease of the IRBMS score
IRBMS (Rosenberg Self-Esteem Scale), minimum score is 10, maximum score is 40
Measured: 4 to 18 months
- For all patients decrease of the DLQI score
DLQI (Dermatology Life Quality Index), minimum score is 0, maximum score is 30
Measured: 4 to 18 months
For only Acne patients, at least 20% reduction in the ECLA score
ECLA ("Echelle de Cotation des Lésions d'Acné" or Acne Lesion Score Scale), minimum score is 0, maximum score is 36
Measured: 4 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start20 Jan 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive HairinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurofeedback
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655129
- Sponsor's protocol ID
- 13330805
- Acronym
- Anthelia
- Status last verified
- Oct 2024
- First submitted
- 23 Apr 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Study of an Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder
- ClinicalTrials.gov ID
- NCT06655129
- Acronym / sponsor ID
- Anthelia / 13330805
- Conditions
- Excessive Hairiness, Vascular Lesion, Pigmented Lesions, Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- EurofeedbackIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first IPL device obtained United States Food and Drug Administration (FDA) clearance in 1995 for treatment of lower extremity telangiectasias. Since then, its favorable cost and versatility in contrast to many singlespectrum lasers, has led to its rapid proliferation and use in a number of different clinical settings. As described in the literature, ANTHÉLIA medical device is intended to treat skin disorders:
- Excessive Hairiness (Hirsutism, Hypertrichosis...)
- Vascular lesions (Rosacea….)
- Pigmented lesions (Lentigo et melasma)
- Acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intense Pulsed Light Treatment | Experimental | Device: intense pulsed lightPatients will be treated at different visits, and according to the IFU, with the Anthelia Medical Device (Intense Pulsed Light). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adult men or women
- Excessive Hairiness:
- Patient with unwanted hair on the body (legs, arms, bikini line, or axilla)
- Patient over 18 years.
- Patients with Fitzpatrick skin types from I to V.
Key exclusion criteria (13 listed)
- Patients with history of malignant lesions or pre-malignant lesions, scarring, or infection in the area to be treated History of keloidal or hypertrophic scarring
- Patients with a known photosensitivity
- Pregnancy women
- Patient with diabetes mellitus suntan in the area to be treated
- Use of photo-sensitizing products for 7 days before treatment (selftanning lotions, activators, self-tanning shower gel, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intense pulsed lightintense pulsed light (IPL) using the Medical Device Anthelia | Device | Intense Pulsed Light Treatment |
Primary outcome
Efficacity for Excessive Hairiness:
Time frame: up to 18 months
Excessive Hairiness by hair counting a 4cm2 surface (To demonstrate a hair reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as six sessions spaced by 12 weeks)
Efficacity for Vascular lesions and Pigmented lesions
Time frame: up to 4 months
Vascular lesions: To demonstrate a reduction of 70% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks. To demonstrate a clinical improvement of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 4 weeks. Pigmented Lesions: To demonstrate a reduction of 60% between the average score of the treated aera before and after a cycle of treatment defined as three sessions spaced by 10 weeks.
Efficacity for Acne vulgaris
Time frame: up to 4 months
measuring the diameter of each pimple in a treated area (before and after), To demonstrate a lesion reduction of 50% between the average score of the treated aera before and after a cycle of treatment defined as five sessions spaced by 2 weeks.
3 secondary outcomes
For all patients decrease of the IRBMS score
Time frame: 4 to 18 months
- For all patients decrease of the DLQI score
Time frame: 4 to 18 months
For only Acne patients, at least 20% reduction in the ECLA score
Time frame: 4 to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Excessive Hairiness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intense pulsed light in people with Excessive Hairiness and Vascular Lesion, run by Eurofeedback at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent Zawadil (01 60 86 31 10, s.qualite@eurofeedback.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacity for Excessive Hairiness: (time frame: up to 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.