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A study to evaluate an AI-based screening tool for detecting common skin diseases

Development of India Health DERM Foundation Model and a DERMA AI application in collaboration with Ajna Lens using open medically fine tuned foundation models from Google Research. - DermaAI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/100006
Enrollment
1000
Registered
2026-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: "Patients will be included in the study if they meet the following criteria: Patients attending Dermatology OPD at AIIMS (and other participating sites) with one of 20 skin diseases Eczema, Acne, Psoriasis, Urticaria, Herpes zoster, Impetigo, Lichen planus, Pityriasis rosea, Tinea (unspecified), Tinea versicolor, Molluscum contagiosum, Rosacea, Seborrheic dermatitis, Scabies, Syphilis, Squamous cell carcinoma (SCC/SCCIS), Cutaneous lupus, Drug rash, Pigmented purpuric eruption / Purpura, Cellulitis / Abscess / Folliculitis Consent for imaging: Patients who provide consent for their skin diseases to be photographed as part of the study. Follow-up visits: Patients returning for follow-up visits for the specified 20 skin diseases will be included provided their current skin disease has not fully recovered. However, patients already enrolled for the mentioned disease previously in the study would be excluded. Types of patients: New patient: This refers to a patient who is being entered into the AI application by a dermatologist for the first time after the study has commenced. The patient may have received consultations prior to the study but has not been entered into the AI application during the study period. Additionally, if a patient had previously visited after the commencement of the study but was not entered into the AI application for any reason, they will also be considered a new patient. Follow up patient: This refers to a patient who has already received a consultation by a dermatologist after the study began and was entered into the AI application, but has either developed a skin condition on a different part of the body or a new skin disease (among the 20 specified skin diseases), requiring further consultation."

Exclusion criteria

Exclusion criteria: Patients less than 18 years, pregnant women, or individuals unable to provide informed consent; vulnerable populations as defined by AIIMS Ethics Committee. Inability to Diagnose or Assess: Patients who are unable to be diagnosed or seen by a Dermatologist for one of the specific skin diseases. Follow-up visits with complete recovery: Patients returning for follow-up visits for the specified skin diseases will be excluded provided their current skin disease has fully recovered. However, if the patient has developed a similar or different skin disease, they will be considered, even if they have previously received treatment for a skin disease. Multiple Skin Diseases: Patients presenting with multiple skin diseases on the same body part will be excluded to ensure that the data collected pertains to a single, specific skin disease for accurate analysis. However, if the multiple skin diseases are on different body parts, the image should be considered for evaluation.

Design outcomes

Primary

MeasureTime frame
To assess the diagnostic performance of the India Health DERM foundation model and the DERMA AI application in screening and identifying selected skin diseases including Tinea, Eczema, Psoriasis, Acne, Melasma, and Vitiligo etc against the dermatologist-confirmed gold standard (GS). The evaluation will be based on key diagnostic parameters such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Timepoint: 2 months

Secondary

MeasureTime frame
evaluate user incorporation, acceptance, usability, (SUS score), and trust among healthcare providers using the CHW/ provider surveyTimepoint: after completion of user testing phase 2 months

Countries

India

Contacts

Public ContactDr Somesh Gupta

All India Institute of Medical Sciences (AIIMS) ANSARI NAGAR, NEW DELHI-

someshgupta@aiims.edu9868899120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026