Hair DamageNCT04489576
Evaluation of Safety and Efficacy of Keratin Hair Therapy
A study testing Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®) in people with Hair Damage, run by Sohag University at 1 site in Egypt.
Trial summary
Hair appearance is an important issue for females. Treatment of hair with keratin has been popular among females nowadays. Although chemical hair straightening application has a beneficial effect on hair shafts with the repair of the broken cuticle, some side effects may occur. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Damage
- What is being tested?
- Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2020to Jun 2021
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study will include female patients aged between 18 and 55 years, with hair curl types from III to V according to L'Oréal Curl Classification. The Patients will be randomized by simple randomization into 3 groups, 10 patients for each.
Who cannot join
- Pregnant and lactating women.
- Patients having hair loss or under treatment of hair loss in last 3 months.
- Patients with previous history of keratin treatment.
- Patients with scalp affection including infection, injury or surgery
- Patients with chronic medical diseases.
- Patients with anemia (hemoglobin level <10mg/dl) or under its treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, 82524
Amr Abdelhamed, MD, 01005825574, dramr80@yahoo.com
About this study
Official title: Efficacy and Safety of Keratin Hair Therapy on the Health of Hair and Scalp
Hair appearance is an important issue for females. Treatment of hair with keratin has been popular among females nowadays. Although chemical hair straightening application has a beneficial effect on hair shafts with the repair of the broken cuticle, some side effects may occur. Therefore, this study aims to study the efficacy and safety of such new non-formaldehyde widely used keratin treatments on hair by assessment of changes of the scalp, hair density, and the morphology, color, and ultrastructure of hair shaft after application.
Read the detailed description
Hair is an important feature for most women that contribute to one's individual identity. The appearance and morphology of the hair is one of the divergent traits in humans. Keratin in hair care products has two effects; it can penetrate the cortex of the hair fiber improving the mechanical properties of damaged fibers and promotes a surface coating that prevents or decreases water diffusion through the hair fibers.These properties have beneficial effects on the hair structure replacing lost keratin.However, the side effects and safety of this treatment have not yet been completely evaluated.There are many different brands of the keratin hair treatment, all with nearly the same basic chemical composition. Non-formaldehyde containing keratin straightening products, also known as safe keratin treatments (SKT) have recently been introduced to the market.Therefore, this study aims to study the efficacy and safety of such new non formaldehyde widely used keratin treatments on hair.
- Conditions
- Hair Damage
- Being tested
- Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)
- Keywords
- Hair keratin, Hair straightening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)Procedure or surgery
Also called Hair straightening treatment
Hair will be treated with 2 different types of keratin in groups 1 \& 2. All steps of keratin application will be done in group 3 without keratin application as a control group.
| Study group | Role | What they receive |
|---|---|---|
| Group (1): Treatment with keratin cure hair | Active comparator | Group (1): Patients will be treated with Keratin cure ® hair treatment. It will be applied once with use of a flat iron. Receives: Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®) |
| Group (2): Treatment with Qod max keratin hair | Active comparator | Group (2): Patients will be treated with QOD Max ® keratin hair treatment. It will be applied once with use of a flat iron. Receives: Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®) |
| Group (3): Treatment without keratin hair treatment | Placebo comparator | Group (3): Patients will be treated without keratin hair treatment, but the same steps of keratin application will be followed. Receives: Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hair shedding using the Visual analogue scale (VAS)
It will be used to evaluate hair shedding. Hair shedding is scored on a scale of 1-6. Women are asked to look at the scale and point to the photograph that best correlates with the amount of hair shed on an average day. Grades 1-3 are considered normal. Grade 4 is borderline, while Grades 5 and 6 indicate excessive shedding.
Measured: Baseline, 2 months, 4 months, 6 months
Change of hair morphology using trichoscope
It will be used to evaluate hair structure and scalp. Hair density/cm 2 and thickness (mm) will be measured in the frontal, temporal and vertex areas in all participants.
Measured: Baseline, 2 months, 4 months, 6 months
Change of hair morphology using Transmission Electron Microscopic examination
Randomly selected samples of each group will be fixed in 3% glutaraldehyde for over a period of 4 hours at 4°C and processed to be examined by transmission electron microscope
Measured: Baseline, 2 months, 4 months, 6 months
Safety evaluation
to detect any side effects that will be reported either by the patient or by the physician.
Measured: at 6 months
Secondary outcomes (1)
Change of patient satisfaction questionnaire about keratin treatment
A 5 items Questionnaire will be completed by the patients to evaluate their satisfaction about the treatment. The questionnaire consists of Q1 (1-5), Q2,3 (1-7), Q4 (1-4) and Q5 has 3 sub-items Q5a, Q5b, Q5c (1-5 for each). Total score ranges from 7-38. Higher scores are associated with higher dissatisfaction.
Measured: Baseline, 2 months, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start15 Nov 2020
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair DamageStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Keratin hair application
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdelhamed, Sohag University
- Investigators
- Amr Abdelhamed, MD, Principal investigator, Faculty of Medicine, Sohag University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489576
- Sponsor's protocol ID
- Sohagu310
- Status last verified
- Jan 2021
- First submitted
- 22 Jul 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data sharing plan will include the study protocol, statistical analysis plan, and the clinical study report.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Keratin Hair Therapy on the Health of Hair and Scalp
- ClinicalTrials.gov ID
- NCT04489576
- Acronym / sponsor ID
- Sohagu310
- Conditions
- Hair Damage
- Keywords
- Hair keratin, Hair straightening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 28 Jul 2020 (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.
Hair appearance is an important issue for females. Treatment of hair with keratin has been popular among females nowadays. Although chemical hair straightening application has a beneficial effect on hair shafts with the repair of the broken cuticle, some side effects may occur. Therefore, this study aims to study the efficacy and safety of such new non-formaldehyde widely used keratin treatments on hair by assessment of changes of the scalp, hair density, and the morphology, color, and ultrastructure of hair shaft after application.
Detailed description
Hair is an important feature for most women that contribute to one's individual identity. The appearance and morphology of the hair is one of the divergent traits in humans. Keratin in hair care products has two effects; it can penetrate the cortex of the hair fiber improving the mechanical properties of damaged fibers and promotes a surface coating that prevents or decreases water diffusion through the hair fibers.These properties have beneficial effects on the hair structure replacing lost keratin.However, the side effects and safety of this treatment have not yet been completely evaluated.There are many different brands of the keratin hair treatment, all with nearly the same basic chemical composition. Non-formaldehyde containing keratin straightening products, also known as safe keratin treatments (SKT) have recently been introduced to the market.Therefore, this study aims to study the efficacy and safety of such new non formaldehyde widely used keratin treatments on hair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Keratin hair application
| Arm | Type | Receives |
|---|---|---|
| Group (1): Treatment with keratin cure hair | Active comparator | Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)Group (1): Patients will be treated with Keratin cure ® hair treatment. It will be applied once with use of a flat iron. |
| Group (2): Treatment with Qod max keratin hair | Active comparator | Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)Group (2): Patients will be treated with QOD Max ® keratin hair treatment. It will be applied once with use of a flat iron. |
| Group (3): Treatment without keratin hair treatment | Placebo comparator | Procedure: Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)Group (3): Patients will be treated without keratin hair treatment, but the same steps of keratin application will be followed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study will include female patients aged between 18 and 55 years, with hair curl types from III to V according to L'Oréal Curl Classification. The Patients will be randomized by simple randomization into 3 groups, 10 patients for each.
Key exclusion criteria (6 listed)
- Pregnant and lactating women.
- Patients having hair loss or under treatment of hair loss in last 3 months.
- Patients with previous history of keratin treatment.
- Patients with scalp affection including infection, injury or surgery
- Patients with chronic medical diseases.
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 |
|---|---|---|
| Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)Also: Hair straightening treatmentHair will be treated with 2 different types of keratin in groups 1 \& 2. All steps of keratin application will be done in group 3 without keratin application as a control group. | Procedure or surgery | Group (1): Treatment with keratin cure hair, Group (2): Treatment with Qod max keratin hair, Group (3): Treatment without keratin hair treatment |
Primary outcome
Change of hair shedding using the Visual analogue scale (VAS)
Time frame: Baseline, 2 months, 4 months, 6 months
It will be used to evaluate hair shedding. Hair shedding is scored on a scale of 1-6. Women are asked to look at the scale and point to the photograph that best correlates with the amount of hair shed on an average day. Grades 1-3 are considered normal. Grade 4 is borderline, while Grades 5 and 6 indicate excessive shedding.
Change of hair morphology using trichoscope
Time frame: Baseline, 2 months, 4 months, 6 months
It will be used to evaluate hair structure and scalp. Hair density/cm 2 and thickness (mm) will be measured in the frontal, temporal and vertex areas in all participants.
Change of hair morphology using Transmission Electron Microscopic examination
Time frame: Baseline, 2 months, 4 months, 6 months
Randomly selected samples of each group will be fixed in 3% glutaraldehyde for over a period of 4 hours at 4°C and processed to be examined by transmission electron microscope
Safety evaluation
Time frame: at 6 months
to detect any side effects that will be reported either by the patient or by the physician.
1 secondary outcome
Change of patient satisfaction questionnaire about keratin treatment
Time frame: Baseline, 2 months, 4 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: Yes. Individual participant data sharing plan will include the study protocol, statistical analysis plan, and the clinical study report.
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.
Amr Abdelhamed, MD principal investigator
Faculty of Medicine, Sohag University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®) in people with Hair Damage, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 6 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 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. Some participants in this study may receive a placebo. 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 Amr Abdelhamed, MD (+201005825574 ext. 0020, dramr80@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of hair shedding using the Visual analogue scale (VAS) (time frame: Baseline, 2 months, 4 months, 6 months). The study lists 4 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 11 Jan 2021.