Dermatology Clinical Research · India
Dermatology Clinical Trials in India, From Topicals to Biologics
Shen Clinical Services runs dermatology clinical trials in India for topical, oral and biologic treatments, from Phase I to Phase IV. We cover psoriasis, atopic dermatitis, tinea, vitiligo, acne and urticaria, plus topical bioequivalence and cosmetic studies, with protocol design, CDSCO and ethics approvals, dermatology site selection, standardised photography, rater training, data management and safety reporting.
0.44% to 2.8%Psoriasis among dermatology patients
Types III to VIFitzpatrick skin types
90 working daysCDSCO trial decision
Phase I to IVTopicals, orals and biologics
On this page
Why India
Why Run Dermatology Clinical Trials in India
India combines large patient pools for common skin diseases, diverse skin types and a time-bound approval process.
Large Patient Pools
Hospital-based studies put psoriasis at 0.44% to 2.8% of dermatology patients in India, giving well-defined pools for psoriasis and eczema trials.
Urgent Antifungal Need
The IADVL task force reports an unprecedented rise in chronic, recurrent and steroid-modified tinea, with reduced response to standard antifungal treatment.
Diverse Skin Types
Trials can enrol patients with Fitzpatrick skin types III to VI, strengthening data for pigmentary disorders and skin of colour.
Time-Bound Approvals
CDSCO decides on a trial application within 90 working days, or 30 working days for drugs discovered and developed in India.
Indications
Dermatology Indications and Endpoints We Cover
We design and run dermatology clinical research across the main skin conditions:
| Indication | Typical studies | Common endpoints |
|---|---|---|
| Psoriasis | Topical, oral, biologic and biosimilar trials | PASI 75 / PASI 90; physician global assessment; body surface area |
| Atopic dermatitis | Topical and systemic trials, including children | EASI 75; IGA 0/1; itch numeric rating scale |
| Dermatophytosis (tinea) | Antifungal efficacy and relapse studies | Mycological cure (KOH and culture); clinical and complete cure |
| Vitiligo | Topical and phototherapy combination trials | Repigmentation measured by facial and total VASI |
| Acne | Topical and oral therapy trials | Lesion counts; IGA success |
| Chronic urticaria | Antihistamine and biologic trials | Weekly urticaria activity score (UAS7) |
| Cosmetics and topicals | Safety, irritation and claim-support studies | Patch test reactions; instrumental skin measurements |
Trial Operations
How We Make Dermatology Data Reliable
Skin trials depend on consistent visual scoring. We set up and manage:
- Dermatology sites: investigators at dermatology departments and skin clinics across India
- Standardised photography: fixed lighting, positions and image review
- Rater training: calibration on PASI, EASI, IGA and VASI to reduce variability between sites
- Mycology: KOH microscopy and culture through central laboratories for antifungal trials
- Topical bioequivalence: clinical endpoint studies and vasoconstrictor studies for corticosteroids
- Patient-reported outcomes: itch scores, DLQI and electronic diaries
- Approvals: CDSCO permission in Form CT-04/CT-06, ethics approvals and CTRI registration
Learn more about our clinical trial protocol design and clinical data management services.
Our Process
How We Run Your Dermatology Trial
STEP 01
Feasibility and Sites
We check patient numbers and standard of care, then select dermatology sites and investigators.
STEP 02
Protocol and Approvals
We write the protocol and file for CDSCO permission, ethics approvals and CTRI registration.
STEP 03
Conduct and Monitor
We train raters, start up sites and monitor scoring, photography, dosing and source data.
STEP 04
Data, Safety and Reports
We manage data, report serious adverse events on time and deliver the study report.
Why Shen
Why Choose Shen as Your Dermatology CRO in India
Physician-Led Oversight
Medically qualified team members review protocols, eligibility and skin safety findings throughout the study.
Regulatory Under One Roof
The same team handles CDSCO, ethics and CTRI filings for drugs and registration for cosmetics.
Dermatology Site Network
We work with investigators at dermatology departments and skin clinics across India.
One Partner, Full Service
Monitoring, data management, pharmacovigilance and medical writing from a single team.
What We Cover
Our Dermatology Clinical Research Services
Feasibility and site selection
Protocol and study design
CDSCO trial permission
Ethics committee submissions
CTRI registration
Site start-up and monitoring
Rater training and photography
Topical bioequivalence studies
Cosmetic safety and claim studies
Clinical data management
Pharmacovigilance and SAE reporting
Medical writing and CSRs
FAQs
Dermatology Clinical Trials in India: Frequently Asked Questions
Why run dermatology clinical trials in India?
India offers large patient pools for common skin diseases, a wide range of skin types (Fitzpatrick III to VI) and a time-bound CDSCO approval process. Indian dermatologists also report a sharp rise in chronic and steroid-modified tinea, which makes India a key location for antifungal research.
How long does CDSCO take to approve a dermatology trial?
Under Rule 22 of the New Drugs and Clinical Trials Rules, 2019, CDSCO decides on a clinical trial application within 90 working days. For drugs discovered in India, or researched and to be manufactured and marketed in India, Rule 23 sets 30 working days.
How is efficacy measured in psoriasis and eczema trials?
Psoriasis trials usually use the Psoriasis Area and Severity Index (PASI), with PASI 75 or PASI 90 response as key endpoints, alongside a physician global assessment. Atopic dermatitis trials use the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA) and patient-reported itch scores. Trained, calibrated raters keep these scores consistent across sites.
How are generic topical products shown to be bioequivalent?
Because most topical drugs act locally, equivalence is usually shown through a comparative clinical endpoint study in patients. For topical corticosteroids, a vasoconstrictor (skin blanching) study is commonly used. The exact approach is agreed with the regulator for each product.
Do cosmetics need clinical trials in India?
No CDSCO clinical trial permission is needed for cosmetics, which are regulated under the Cosmetics Rules, 2020, and imported cosmetics need a registration certificate. Many brands still run safety, patch test and claim-support studies to back their product claims.
Can children be included in dermatology trials?
Yes, where the condition affects children, as with atopic dermatitis. Paediatric trials need consent from a parent or legal guardian and assent from children old enough to give it, in line with the NDCT Rules and ICMR ethical guidelines.
Resource Spotlight
Launching a skin care brand? See our cosmetic registration in India service. Developing a psoriasis biosimilar? See our biosimilar development services.
Start Your Dermatology Clinical Trial in India
Planning a skin study? Share your protocol synopsis for a feasibility and budget estimate.
Running a global trial? We can add Indian sites and manage them locally.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: Dogra and Yadav, Psoriasis in India: prevalence and pattern (IJDVL, 2010); IADVL ITART consensus on glabrous tinea (IDOJ, 2020); New Drugs and Clinical Trials Rules, 2019 (CDSCO); Clinical Trials Registry – India. General regulatory information, not legal advice.