SafetyHRIPT + FOTONCT07797192
Evaluation of Allergenicity by HRIPT and Phototest
A study testing Blancy Pro in people with Safety, run by Brainfarma Industria Química e Farmacêutica S/A at 1 site in Brazil.
Trial summary
This clinical study will evaluate the dermatological safety and allergenic potential of a cosmetic product. The study will use the Human Repeat Insult Patch Test (HRIPT) and phototest procedures to assess whether the product may cause skin irritation, allergic reactions, photoirritation, or photosensitization after… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- Blancy Pro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Jul 2026to 25 Aug 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants aged 18 to 70 years.
- Fitzpatrick skin phototypes I, II, III, or IV.
- Intact skin at the application site.
- Willingness to comply with all study procedures and attend scheduled clinic visits for medical assessments, patch applications, and patch readings.
- Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).
- For the phototest procedure, only participants with Fitzpatrick skin phototypes II and III will be eligible.
Who cannot join
- Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
- Use of anti-inflammatory medications within 30 days prior to screening or immunosuppressive medications within 3 months prior to screening.
- Immunosuppression due to medication use or active disease.
- Uncontrolled endocrine disorders.
- Personal history of atopy.
- Intense sun exposure or tanning sessions within 15 days prior to assessment or during the study period.
Show all 30Show fewer
- Planned intense sun exposure or tanning sessions during the study period.
- Planned sea bathing, swimming pool use, or sauna sessions during the study period.
- Participation in water sports during the study period.
- Dermographism.
- Use of oral or topical vitamin A acid (retinoids) or related derivatives within 1 week prior to study initiation.
- Aesthetic and/or dermatological body treatments within 3 weeks prior to screening.
- Scheduled vaccination during the study period or within 3 weeks prior to screening.
- History of sensitization, irritation, or photosensitization to topical products.
- Active local or generalized skin diseases that may interfere with study assessments.
- Skin hyperreactivity.
- Initiation of new medications during the study period.
- Previous participation in studies involving the same investigational product.
- Congenital or acquired immunodeficiency.
- Relevant medical history or current evidence of alcohol or substance abuse.
- Known or suspected intolerance to any ingredient contained in the investigational or comparator products.
- History of poor compliance or unwillingness to comply with the study protocol.
- Employees of the study site, sponsor, or their immediate family members directly involved in the study.
- Any other condition that, in the investigator's opinion, may interfere with study participation or justify exclusion from the study.
- Additional Exclusion Criteria for the Phototest:
- History of diseases aggravated or triggered by ultraviolet radiation.
- Use of photosensitizing medications.
- History or current presence of photodermatoses.
- Personal or family history of skin cancer.
- Presence of precancerous skin lesions, including melanocytic nevi or actinic keratoses, that may interfere with study assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Allergenic Potential of a Cosmetic Product Using the Human Repeat Insult Patch Test (HRIPT) and Phototest
This clinical study will evaluate the dermatological safety and allergenic potential of a cosmetic product. The study will use the Human Repeat Insult Patch Test (HRIPT) and phototest procedures to assess whether the product may cause skin irritation, allergic reactions, photoirritation, or photosensitization after repeated use and exposure to ultraviolet light.
Participants will receive applications of the investigational product under controlled conditions and will undergo dermatological evaluations throughout the study. The results will help determine the product's skin compatibility and safety for consumer use.
Read the detailed description
This is a single-center, single-blind, non-comparative clinical study designed to evaluate the dermal compatibility and allergenic potential of an investigational cosmetic product using the Human Repeat Insult Patch Test (HRIPT) and phototest procedures.
The HRIPT phase will assess primary dermal irritation, cumulative irritation, and skin sensitization potential through repeated applications of patches containing the investigational product to the participants' backs under maximized conditions. The practical phase lasts six weeks and includes three weeks of product application, two weeks of rest, and one challenge week with product reapplication on a previously untreated skin site.
The phototest phase will assess the photoirritant and photosensitizing potential of the investigational product following controlled exposure to ultraviolet radiation. Product-containing patches will be applied to the skin and, after removal, the test sites will undergo controlled ultraviolet irradiation. The practical phase lasts five weeks and includes induction, rest, and challenge phases.
Dermatological evaluations will be performed according to standardized criteria, including assessments based on the International Contact Dermatitis Research Group (ICDRG) scale, to confirm the absence of clinically significant irritant, allergenic, photoirritant, or photosensitizing reactions.
- Conditions
- Safety
- Being tested
- Blancy Pro
- Keywords
- HRIPT, Phototest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blancy ProOther
Blancy Pro is a cosmetic product evaluated for dermatological safety, skin sensitization, photoirritation, and photosensitization potential. Participants will undergo Human Repeat Insult Patch Test (HRIPT) and phototest procedures involving repeated applications of the product under controlled conditions, followed by dermatological assessments to evaluate skin compatibility and the absence of allergenic reactions.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Cosmetic Product | Experimental | Participants will undergo Human Repeat Insult Patch Test (HRIPT) and phototest procedures using the investigational cosmetic product to evaluate dermatological safety, skin irritation, skin sensitization, photoirritation, and photosensitization potential. Receives: Other: Blancy Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria
Dermal irritation following application of Blancy Pro will be assessed using the Human Repeat Insult Patch Test (HRIPT). Patches containing the investigational product and control patches (saline solution, mineral oil, patch without product, and adhesive tape control) will be applied to the lateral back. Skin reactions will be evaluated 48 hours (Day 3) and 96 hours (Day 5) after application according to the International Contact Dermatitis Research Group (ICDRG) grading scale. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Measured: Day 3 and Day 5
Cumulative Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria
Cumulative dermal irritation following repeated applications of Blancy Pro will be assessed using the Human Repeat Insult Patch Test (HRIPT). Patches containing the investigational product and control materials will be repeatedly applied to the lateral back over a 3-week induction period. Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Measured: Day 3, Day 5, Day 8, Day 10, Day 12, Day 15, Day 17, and Day 19
Dermal Sensitization Assessed by Human Repeat Insult Patch Test (HRIPT) Challenge Phase Using ICDRG Criteria
Dermal sensitization following repeated application of Blancy Pro will be assessed during the Human Repeat Insult Patch Test (HRIPT) challenge phase. After a two-week rest period, patches containing the investigational product and control materials will be applied to previously unexposed skin sites. Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Measured: Day 38 and Day 39
Dermal Photoirritation Assessed by Phototest Using ICDRG Criteria
Dermal photoirritation following application of Blancy Pro will be assessed using phototest procedures. Patches containing the investigational product and control materials (saline solution, mineral oil, patch without product, and adhesive tape control) will be applied to the medial back. After 24 hours, patches will be removed, skin reactions will be assessed, and the test sites will be exposed to ultraviolet A (UVA) radiation at a dose of 5 J/cm². Additional assessments will be performed 48 hours after irradiation according to the International Contact Dermatitis Research Group (ICDRG) grading criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Measured: Day 2 and Day 4
Dermal Photosensitization Assessed by Phototest Induction Phase Using ICDRG Criteria
Dermal photosensitization following repeated application of Blancy Pro and controlled ultraviolet A (UVA) exposure will be assessed during the phototest induction phase. Patches containing the investigational product and control materials will be applied to the medial back and irradiated with UVA at a dose of 5 J/cm². Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Measured: Day 2, Day 4, Day 5, Day 8, Day 10, and Day 12
Dermal Photosensitization Assessed by Phototest Challenge Phase Using ICDRG Criteria
Dermal photosensitization following repeated application of Blancy Pro will be assessed during the phototest challenge phase. After a two-week rest period, patches containing the investigational product and control materials will be applied to two previously unexposed skin sites. One test area will be irradiated with ultraviolet A (UVA) radiation at a dose of 5 J/cm². Skin reactions in both test areas will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Measured: Day 30 and Day 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start13 Jul 2026
- Primary completion25 Aug 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergio Schalka, Principal investigator, Grupo Medcin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797192
- Sponsor's protocol ID
- 26-0161-01/02
- Acronym
- HRIPT + FOTO
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 16 Sep 2026
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Allergenic Potential of a Cosmetic Product Using the Human Repeat Insult Patch Test (HRIPT) and Phototest
- ClinicalTrials.gov ID
- NCT07797192
- Acronym / sponsor ID
- HRIPT + FOTO / 26-0161-01/02
- Conditions
- Safety
- Keywords
- HRIPT, Phototest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 1 Sep 2026 (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.
This clinical study will evaluate the dermatological safety and allergenic potential of a cosmetic product. The study will use the Human Repeat Insult Patch Test (HRIPT) and phototest procedures to assess whether the product may cause skin irritation, allergic reactions, photoirritation, or photosensitization after repeated use and exposure to ultraviolet light.
Participants will receive applications of the investigational product under controlled conditions and will undergo dermatological evaluations throughout the study. The results will help determine the product's skin compatibility and safety for consumer use.
Detailed description
This is a single-center, single-blind, non-comparative clinical study designed to evaluate the dermal compatibility and allergenic potential of an investigational cosmetic product using the Human Repeat Insult Patch Test (HRIPT) and phototest procedures.
The HRIPT phase will assess primary dermal irritation, cumulative irritation, and skin sensitization potential through repeated applications of patches containing the investigational product to the participants' backs under maximized conditions. The practical phase lasts six weeks and includes three weeks of product application, two weeks of rest, and one challenge week with product reapplication on a previously untreated skin site.
The phototest phase will assess the photoirritant and photosensitizing potential of the investigational product following controlled exposure to ultraviolet radiation. Product-containing patches will be applied to the skin and, after removal, the test sites will undergo controlled ultraviolet irradiation. The practical phase lasts five weeks and includes induction, rest, and challenge phases.
Dermatological evaluations will be performed according to standardized criteria, including assessments based on the International Contact Dermatitis Research Group (ICDRG) scale, to confirm the absence of clinically significant irritant, allergenic, photoirritant, or photosensitizing reactions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Cosmetic Product | Experimental | Other: Blancy ProParticipants will undergo Human Repeat Insult Patch Test (HRIPT) and phototest procedures using the investigational cosmetic product to evaluate dermatological safety, skin irritation, skin sensitization, photoirritation, and photosensitization potential. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female participants aged 18 to 70 years.
- Fitzpatrick skin phototypes I, II, III, or IV.
- Intact skin at the application site.
- Willingness to comply with all study procedures and attend scheduled clinic visits for medical assessments, patch applications, and patch readings.
- Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).
Key exclusion criteria (30 listed)
- Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
- Use of anti-inflammatory medications within 30 days prior to screening or immunosuppressive medications within 3 months prior to screening.
- Immunosuppression due to medication use or active disease.
- Uncontrolled endocrine disorders.
- Personal history of atopy.
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 |
|---|---|---|
| Blancy ProBlancy Pro is a cosmetic product evaluated for dermatological safety, skin sensitization, photoirritation, and photosensitization potential. Participants will undergo Human Repeat Insult Patch Test (HRIPT) and phototest procedures involving repeated applications of the product under controlled conditions, followed by dermatological assessments to evaluate skin compatibility and the absence of allergenic reactions. | Other | Investigational Cosmetic Product |
Primary outcome
Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria
Time frame: Day 3 and Day 5
Dermal irritation following application of Blancy Pro will be assessed using the Human Repeat Insult Patch Test (HRIPT). Patches containing the investigational product and control patches (saline solution, mineral oil, patch without product, and adhesive tape control) will be applied to the lateral back. Skin reactions will be evaluated 48 hours (Day 3) and 96 hours (Day 5) after application according to the International Contact Dermatitis Research Group (ICDRG) grading scale. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Cumulative Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria
Time frame: Day 3, Day 5, Day 8, Day 10, Day 12, Day 15, Day 17, and Day 19
Cumulative dermal irritation following repeated applications of Blancy Pro will be assessed using the Human Repeat Insult Patch Test (HRIPT). Patches containing the investigational product and control materials will be repeatedly applied to the lateral back over a 3-week induction period. Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Dermal Sensitization Assessed by Human Repeat Insult Patch Test (HRIPT) Challenge Phase Using ICDRG Criteria
Time frame: Day 38 and Day 39
Dermal sensitization following repeated application of Blancy Pro will be assessed during the Human Repeat Insult Patch Test (HRIPT) challenge phase. After a two-week rest period, patches containing the investigational product and control materials will be applied to previously unexposed skin sites. Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Dermal Photoirritation Assessed by Phototest Using ICDRG Criteria
Time frame: Day 2 and Day 4
Dermal photoirritation following application of Blancy Pro will be assessed using phototest procedures. Patches containing the investigational product and control materials (saline solution, mineral oil, patch without product, and adhesive tape control) will be applied to the medial back. After 24 hours, patches will be removed, skin reactions will be assessed, and the test sites will be exposed to ultraviolet A (UVA) radiation at a dose of 5 J/cm². Additional assessments will be performed 48 hours after irradiation according to the International Contact Dermatitis Research Group (ICDRG) grading criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Dermal Photosensitization Assessed by Phototest Induction Phase Using ICDRG Criteria
Time frame: Day 2, Day 4, Day 5, Day 8, Day 10, and Day 12
Dermal photosensitization following repeated application of Blancy Pro and controlled ultraviolet A (UVA) exposure will be assessed during the phototest induction phase. Patches containing the investigational product and control materials will be applied to the medial back and irradiated with UVA at a dose of 5 J/cm². Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Dermal Photosensitization Assessed by Phototest Challenge Phase Using ICDRG Criteria
Time frame: Day 30 and Day 32
Dermal photosensitization following repeated application of Blancy Pro will be assessed during the phototest challenge phase. After a two-week rest period, patches containing the investigational product and control materials will be applied to two previously unexposed skin sites. One test area will be irradiated with ultraviolet A (UVA) radiation at a dose of 5 J/cm². Skin reactions in both test areas will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Sergio Schalka principal investigator
Grupo Medcin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blancy Pro in people with Safety, run by Brainfarma Industria Química e Farmacêutica S/A at 1 site in Brazil.
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 6 inclusion and 30 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: finished, as of the sponsor's last update on 16 Sep 2026. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria (time frame: Day 3 and Day 5). The study lists 6 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 16 Sep 2026.