HRIPT Testing and In Vivo Cosmetic Safety Studies
SHAPYPRO coordinates HRIPT testing and other in vivo cosmetic safety studies to assess product tolerance, compatibility and acceptability under controlled conditions of use.
The study design may include HRIPT, RIPT, patch tests, usage tests and other evaluations selected according to the product type, application area, target population and claim to be supported.
- HRIPT and RIPT
- Skin compatibility
- Clinical supervision
- Technical reports
In Vivo Cosmetic Safety Testing
In vivo cosmetic safety testing evaluates the response of the skin to a finished product under a defined protocol and professional supervision.
These studies provide information on irritation, tolerance, compatibility, acceptability and possible reactions associated with product use. The results may complement toxicological, microbiological and stability data already available for the formulation.
Clinical studies do not replace the cosmetic product safety assessment or the report prepared by a qualified safety assessor. They provide additional evidence about product behaviour within the specific conditions of the study.
Types of Studies: HRIPT, RIPT and Compatibility
The study design depends on the technical objective, product type and information required. Available safety documentation must be reviewed before an in vivo study begins to confirm that the product is suitable for application to volunteers.
HRIPT / RIPT · Human Repeat Insult Patch Test
A repeated patch application study that commonly includes an induction phase, a rest period and a challenge phase.
It is used to assess skin tolerance following repeated exposure and to investigate the irritation or sensitisation potential of a formulation within the population and conditions defined by the protocol.
Skin Compatibility Patch Test
A single or short-duration application, generally under occlusive or semi-occlusive conditions, used to assess signs of irritation and skin compatibility.
Open Test and ROAT
Single or repeated open application to a defined skin area. A Repeat Open Application Test helps assess tolerance following continued use over a specified period.
Usage Test
An evaluation performed under conditions close to intended use. Participants use the product according to defined instructions, while tolerance, acceptability and possible incidents are recorded.
Non-Comedogenicity Test
A study designed to assess whether product use promotes the formation of comedones, particularly for facial products, sunscreens and products intended for acne-prone skin.
Photoirritation and Photosensitisation
Specific studies for products whose use or composition requires evaluation of skin response associated with ultraviolet exposure. They are considered only when technically relevant.
Common Cases
Safety testing may be incorporated at different stages of product development and marketing. Each study should address a defined technical need rather than serve as a generic test unrelated to the formulation or intended claim.
Development of New Products
Assessment of finished-product tolerance and compatibility before market launch or final validation.
Reformulation or Process Changes
Evaluation of changes in ingredients, concentrations, preservatives, fragrances, manufacturing process or product format.
Frequently or Repeatedly Used Products
Studies involving creams, lotions, gels, hygiene products, sunscreens and other formulations applied repeatedly.
Products for Sensitive Skin or Specific Areas
Protocols adapted to the application area, target population and expected conditions of use.
Support for Product Claims
Evidence for claims such as “dermatologically tested”, “non-comedogenic”, “good skin tolerance” or “suitable for sensitive skin”, provided that the protocol and results support the wording used.
Products Evaluated
Studies are adapted to the formulation, method of use, application area and user profile. The preliminary review determines whether the product can enter a clinical protocol and which type of evaluation is appropriate.
Facial Products
Creams, serums, cleansers, toners, masks, anti-ageing products and formulations intended for acne-prone skin.
Body Products
Lotions, emulsions, oils, gels, deodorants and moisturising or frequently used products.
Sunscreen Products
Tolerance and safety-of-use studies, together with specific evaluations related to sun exposure where appropriate.
Hair Care and Hygiene Products
Shampoos, conditioners, gels, soaps and products intended for the scalp or personal hygiene.
Sensitive-Skin Products
Formulations intended for users with specific tolerance needs, assessed using suitable protocols and participant selection criteria.
Process and Technical Safeguards
Each study is planned using the available information on the formula, finished product, intended use and study objectives.
The protocol should define the participant population, inclusion and exclusion criteria, application conditions, assessment times, observed variables and interpretation criteria.
Preliminary Safety Review
Review of the formulation, technical documentation and use profile to confirm that the product can undergo the proposed study.
Protocol Design
Selection of the test type, participant profile, application area, frequency, duration and assessment criteria.
Participant Selection and Information
Application of inclusion and exclusion criteria, provision of study information and collection of informed consent. Ethical review is included where applicable.
Execution and Supervision
Performance under controlled conditions and appropriate professional supervision, with relevant observations and reactions documented.
Follow-Up and Incident Management
Monitoring of tolerance during the study and application of predefined procedures in the event of any reaction or adverse event.
Results, Interpretation and Report
Results must be interpreted according to the protocol, participant population, exposure conditions and criteria defined before the study begins.
The report may include the product and protocol description, characteristics of the study population, clinical findings, recorded incidents, data analysis and applicable conclusions.
A favourable result supports product tolerance under the evaluated conditions, but it does not guarantee the complete absence of reactions in every potential user. Conclusions and claims must remain within the actual scope of the study.
Cosmetic Safety Assessment
Results may complement the information used in the overall safety assessment and product documentation under Regulation (EC) No 1223/2009.
Claim Substantiation
Clinical evidence may support claims related to tolerance, dermatological compatibility, non-comedogenicity or suitability for sensitive skin when the design and results are consistent with the claim.
Development and Reformulation
Comparison of results helps identify issues, assess changes and support decisions before moving to later development stages.
Documentary Traceability
The technical report provides a structured basis for dossiers, internal reviews, audits and communication with quality or regulatory teams.
Safety Studies Adapted to Each Product
Each formulation has a specific use profile and different evaluation needs. SHAPYPRO coordinates the most appropriate study according to the product, application area, frequency of use, target population and intended claim.
The objective is to obtain useful clinical information, clear documentation and conclusions proportionate to the actual scope of the study.
