Evaluation of Allergenicity by HRIPT and Phototest

NCT07797192 | Completed

• 1 other identifier: 26-0161-01/02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Safety

Keywords

HRIPT; Phototest

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Day 30 and Day 32

Study Arms (1)

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.

Other: Blancy Pro

Interventions

Blancy Pro OTHER

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.

Investigational Cosmetic Product

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

Study Sites (1)

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

Location

Study Officials

• Sergio Schalka

  Grupo Medcin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are blinded to the identity, brand name, and commercial information of the study product. The product is applied without disclosure of its name or manufacturer to the participants.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 1, 2026
• Study Start: July 13, 2026
• Primary Completion: August 25, 2026
• Study Completion: August 25, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)