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A study to test the skin safety and allergy potential of an Aloevera cream (Tube) in healthy volunteers

Evaluation of Dermatological Safety and Hypo-Allergenicity of Aloevera Cream Tube by Human Repeat Insult Patch Test (HRIPT) on Healthy Female and Male Volunteers as Per IS 4011. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110244
Enrollment
100
Registered
2026-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Test Arm - Aloevera Cream Tube (Investigational Product): 40 l of investigational product on the pre-cut filter paper placed inside the allotted derma proof Aluminum Finn chamber prefix

Sponsors

Ross Life science Ltd,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy men/women of age between 18 and 65 years. 2. Photo type III to V. 3. Self-declaration of subject with sensitive skin. 4. Having apparently healthy skin on test area. 5. For whom the investigator considers that the compliance will be correct. 6. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures. 7. Having signed a Consent Form

Exclusion criteria

Exclusion criteria: 1.Pregnant/nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area. 3.Dermatological infection/pathology on the level of studied area. 4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye). 5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 6.Chronic illness which may influence the outcome of the study. 7.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). 8.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial

Design outcomes

Primary

MeasureTime frame
1.The dermatological safety and hypo-allergenicity will be assessed by dermatologist. 2.Consumer acceptance of the product will be evaluated by Feedback Questionnaires.Timepoint: Day 1 to Day 40

Secondary

MeasureTime frame
Safety Endpoints- Adverse events (AEs).Timepoint: Day 1 to Day 40

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt Ltd

surya.ashok@gmail.com09880999297

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026