ClinicalTrials.gg
Status unknownNCT01085851Updated Mar 12, 2010

Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms

A Phase 3 interventional study of Dexchlorpheniramine 1% lotion and Dexchlorpheniramine 1% cream in Sunburn, sponsored by Mantecorp Industria Quimica e Farmaceutica Ltd.. Status unknown at 1 site in Brazil. Open to participants aged 2 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-03-12.

Sponsored by Mantecorp Industria Quimica e Farmaceutica Ltd. (part of Hypera Pharma) · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
2 Years to 60 Years
Sex
All
01

Study summary

Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.

02

Conditions studied

  • Sunburn

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Keywords

  • Sunburn
  • Dexchlorpheniramine
  • Lotion
  • Cream
03

In context

Sunburn

29 studies on the registry are indexed under Sunburn; 2 are open to participants now.

This study's planned enrollment of 30 is below the median of 54 across 26 interventional studies indexed under Sunburn.

Browse Sunburn studies →

Lead sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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Inclusion criteria

  • Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
  • Presence of lesions with some degree of symmetry to allow comparison between both pharmaceutical formulations
  • Compliance of the subject to the treatment protocol
  • Agreement with the terms of the by the participants or their legal guardians when younger than 18 years old

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or risk of pregnancy
  • Lactation
  • Signs of solar erythema of severe intensity
  • Use of topical or systemic anti-inflammatory, antihistamine or drugs within the last 48 hours prior to the study
  • History of atopy or allergic diseases
  • History of allergy to any component of the formulations
  • Other conditions considered by the investigator as reasonable for non-eligibility
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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Immunosuppression

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05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Dexchlorpheniramine 1% lotion

    Drug: Dexchlorpheniramine 1% lotion

  • Active comparator
    Dexchlorpheniramine 1% cream

    Drug: Dexchlorpheniramine 1% cream

Interventions

06

What researchers measure

Primary outcomes

  1. Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)

    Time frame: 7 days

Secondary outcomes

  1. Composite clinical evaluation of erythema, pruritus and burning sensation performed by the investigator using a 4-point scale for each one of the variables (absent, mild, moderate, intense).

    Time frame: 7 days

07

Study locations

1 site
  • Medcin Instituto da Pele Ltda
    São Paulo, SP, Brazil
    • Patrícia C Pinto · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01085851
First posted
Mar 12, 2010
Last update
Mar 12, 2010

Study contacts

Sérgio Schalka, MD
Contact
+551136811334
Sérgio Schalka, MD
principal investigator · Medcin Instituto da Pele Ltda

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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