Condition category
Skin and Connective Tissue Diseases
Date applied
25/11/2018
Date assigned
27/11/2018
Last edited
27/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Laser hair removal (LHR) has become one of the most popular treatments in aesthetics. Side effects are an inevitable part of laser therapy, therefore managing them is crucial for every laser practitioner to ensure patients’ safety along with achieving the best results. The available references describe the effectiveness of the diode laser hair removal for all skin types according to the Fitzpatrick scale, but the question of patient safety and minimization of side effects and postoperative complications in mixed-race patients remains unanswered.
: This study aims to illustrate aspects of specific side effects in patients of various ethicities and the impact of those effects on the results of the treatment.
The study is conducted in Poland and the United Kingdom on patients of various ethnic background. This study analyse the frequency of side effects in a patients of various ethnicities , taking into account their skin type according to the Fitzpatrick scale. The patients receive a course of 6 treatments using diode laser 805 nm. An objective and a subjective method were used to analyse treatment results and side effects, with adverse effects documented, if observed. Treatment settings were adjusted to skin reaction during the patch test.

Background and study aims
Laser hair removal (LHR) has become one of the most popular treatments in aesthetics (beauty treatments). A diode laser can be used for hair reduction. Side effects are common, therefore managing them is important for every laser practitioner to ensure patients’ safety along with achieving the best results. Research shows that laser treatment is effective for hair removal in all skin types according to the Fitzpatrick scale (which divides skin into how easily it burns in the sun), but there is a need to investigate side effects in people of different ethnicities.
This study aims to investigate the occurrence and types of side and adverse effects after performing diode laser hair removal in people of various ethnicities including White, Black, Asian and Mixed Race, including participants with all skin types according to the Fitzpatrick scale, and to assess its impact on the results of the treatment measured as a percentage of hair reduction in the treated area.

Who can participate?
Healthy volunteers of both genders, all ethnicities, all skin types, of age 20-40 years.

What does the study involve?
This study involves 6 diode laser treatments in the selected part of the body at 6-week intervals. Hair loss percentage will be measured using before and after photographs, as well as the participant's own estimate of hair reduction. Side effects will be recorded before and after treatment.

What are the possible benefits and risks of participating?
Participants can expect a long-term, stable reduction in the number of hairs re-growing after the course of treatments. Hair reduction would last for 4 to 12 months and permanent hair reduction doesn't mean the elimination of all hairs in the treatment area. The reference point for an excellent result is defined to be an 80% hair loss. There is a risk of side effects, including skin hyperpigmentation, skin redness, skin irritation, skin hypersensitivity, skin burns, discomfort, damage to the natural skin texture, scarring, excessive swelling, blisters and bruising.

Where is the study run from?
Klinika Mlodosci, ul Lakowa 27, Krakow, (Poland)

When is the study starting and how long is it expected to run for?
March 2016 to May 2019

Who is funding the study?
The investigator will pay the trial's costs.

Who is the main contact?
Magdalena Atta-Motte
atta.motte@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Ms Magdalena Atta-Motte

ORCID ID

http://orcid.org/0000-0001-7374-1617

Contact details

21 Kings Avenue
Carshalton
SM5 4NX
United Kingdom
+44 7932857109
magda.atta.motte@consultant.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016/2019 HR

Study information

Scientific title

Aspects of diode laser (805 nm) hair removal safety in people of various ethnicities

Acronym

Study hypothesis

This study aims to investigate the effects of diode laser hair removal in people of different ethnicities, including its effectiveness in removing hair as well as any adverse events.

Ethics approval

University of Physical Education, Krakow (Poland), 28/02/2016. ref: 28022016/2016/2019/HR

Study design

Observational

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Laser treatment of excess hair growth

Intervention

During initial consultations, according to the study protocol and to ensure patients’ safety, investigators assess skin types using the Fitzpatrick Scale Quiz. The Fitzpatrick scale is defined as a classification for human skin colour as a way to estimate the response of different types of skin to light exposure. To define ethnicity, ethnic background questions are asked following the Census 2001 scheme acknowledged in the UK, which categorises ethnicity as White, Black, Asian and Mixed-race.
During the initial consultation, practitioners explain a realistic expected outcome of the course of six treatments. Participants are familiarised with the definition of permanent hair reduction issued by the FDA and the possible result of the treatment as a long-term, stable reduction in the number of hairs re-growing after the course of treatments. Participants are aware that hair reduction would last for 4 to 12 months and permanent hair reduction doesn't mean the elimination of all hairs in the treatment area. The reference point for an excellent result is defined to be an 80% hair loss. Participants are aware of side effects and adverse effects possibilities. Before carrying out the treatment, the patient’s skin was shaved and cleaned, and during the course of six treatments, the patients are not using any other methods of hair removal, as per the therapist's pre- and post- instructions. All participants sign informed consent for treatment and volunteer for participation in the study, and before each of the treatment medical history is checked and signed by participants.
A skin patch test in the area of the treatment is provided for all participants was included in the study. A diode laser with a wavelength of 805 nm, minimum peak power 2100 W and a pulse duration between 15 and 400 ms, ET sapphire cooling assisted handle 9 x 9 mm large, and pulse energy density between 10 and 100 J/cm2 was used for all treatments. This research protocol adheres to patch test treatment settings such as fluence (J/cm2) and pulse duration (ms) as per manufacturer's guidelines for different skin type, hair colour, hair texture and modified according to individual skin reactions.
Patch test settings were starting points for treatments. To achieve the best results and to ensure patients safety (and taking into account their ethnic background and medical history) during each treatment, fluence and pulse width is adjusted to the individual participants' skin reaction. Initial settings and final settings of pulse duration (ms) and fluence (J/cm2) were documented for this study.
All participants are subject to six treatments planned with intervals of 6 weeks. Any side effects, adverse effects, other factors which can have an impact to the results of the study were assessed and documented prior to the treatment. Immediate skin reactions were assessed 15 mins after each treatment. 6 weeks after the last (of 6) treatment, participants attend for a last visit to measure endpoints of the course of the treatments and to share their opinion in regards to the satisfaction level.



Intervention type

Device

Phase

Drug names

Primary outcome measure

1. Objective measurement of hair loss percentage in treatment area assessed by taking photographs with zoom x20 of a 1-cm2 area, 4 cm lower from the middle distance between iliac spines. The number of hairs is counted before the first treatment and 6 weeks after the last treatment.

Secondary outcome measures

1. Subjective assessment of hair loss percentage by participant at 6 weeks after the last treatment
2. Satisfaction level of participant on a 5-point scale
3. Side effects (skin hyperpigmentation, skin redness, skin irritation, skin hypersensitivity, skin burns) assessed before and immediately after each treatment
4. Adverse events (discomfort, damage to the natural skin texture, scarring, excessive swelling, blisters, bruising) assessed before and immediately after each treatment

Overall trial start date

31/03/2016

Overall trial end date

31/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 20-40 years o
2. Undergoing laser hair reduction treatment

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Any previous laser or intense pulsed light (IPL) treatments in the study area
2. Cancer
3. Use of hormonal drugs, photosensitizing drugs or antibiotics
4. Use of cosmetics containing retinol, vitamins A, E, or C, or fruit acids
5. Intake of herbs that can be photosensitizing
6. Suntan
7. Chemical or mechanical depilation or hair bleaching during previous 6 weeks
8. Irritated skin, dermatosis of various etiology, livedo reticularis or photodermatitis
9. Epilepsy
10. Pregnancy and breastfeeding
11. Isotretinoin use within the past year
12. History of photosensitivity
13. History of hypertrophic scars and keloids

Recruitment start date

30/01/2016

Recruitment end date

30/03/2019

Locations

Countries of recruitment

Poland, United Kingdom

Trial participating centre

5th Avenue Medical Clinic
7 Upper Tooting Rd
London
SW17 7TS
United Kingdom

Trial participating centre

Klinika Młodości
ul. Lakowa 27
Krakow
31-443
Poland

Sponsor information

Organisation

Klinika Młodości

Sponsor details

ul. Lakowa 27
Krakow
31-443
Poland

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The first analysis results will be published in Lasers in Medical Science.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes