NCT01542138

Brief Summary

Axillary hyperpigmentation is a frequent consultation in dark skin populations although its exact prevalency is unknown. Currently, there are not studies about physiopathology and treatment for this entity. The objective is to evaluate the depigmenting effect of topical 4% niacinamide versus 0.05% desonide in axillary hyperpigmentation. At least 30 axillas with hyperpigmentation in individuals of phototype III-V, aged 18-50 years are going to be randomly assigned to receive niacinamide, desonide or placebo daily. No hygienic habits will not be modified. Volunteers will be evaluated at baseline and for 9 weeks, by means of histological, histochemical and immunohistochemistry analysis, as well as Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

1.3 years

First QC Date

February 21, 2012

Last Update Submit

November 27, 2012

Conditions

Hyperpigmentation

Keywords

Inflammatory hyperpigmentation, axillar pigmentation

Outcome Measures

Primary Outcomes (1)

  • Pigmentation

    Quantification of melanin content in histologic sections by Fontana-Masson stain

    9 weeks

Secondary Outcomes (4)

  • Inflammation

    9 weeks

  • Trauma

    9 weeks

  • Change in transepidermal water loss in hyperpigmented lesion

    9 weeks

  • Investigator's Depigmentation Improvement

    9 weeks

Study Arms (3)

Niacinamide

ACTIVE COMPARATOR

4% niacinamide cream that will be randomly applied on axillar hyperpigmentation once-a-day for 9 weeks.

Drug: Niacinamide

Desonide

ACTIVE COMPARATOR

Once-a-day application of 0.05% desonide cream on axillar hyperpigmentation

Drug: Desonide

Placebo

PLACEBO COMPARATOR

Humectant placebo cream

Drug: Placebo

Interventions

DesonideDRUG

Once-a-day applying on axillar hyperpigmentation for 9 weeks

Also known as: 0.05% Desowen cream, Galderma, France.
Desonide
NiacinamideDRUG

Once-a-day applying on axillar hyperpigmentation for 9 weeks

Also known as: Nicotinamide, nicomide
Niacinamide
PlaceboDRUG

Humectant placebo cream

Also known as: vanicream, cetaphil
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women over 18 years old
  • Healthy
  • Clinical diagnosis of axillar hyperpigmentation

You may not qualify if:

  • Pregnancy or lactation
  • Obesity
  • Endocrinological diseases
  • Mental diseases
  • Treatment for axillar hyperpigmentation in the last 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, 78210, Mexico

Location

Related Publications (2)

  • Navarrete-Solis J, Castanedo-Cazares JP, Torres-Alvarez B, Oros-Ovalle C, Fuentes-Ahumada C, Gonzalez FJ, Martinez-Ramirez JD, Moncada B. A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma. Dermatol Res Pract. 2011;2011:379173. doi: 10.1155/2011/379173. Epub 2011 Jul 21.

    PMID: 21822427BACKGROUND

  • Torres-Alvarez B, Mesa-Garza IG, Castanedo-Cazares JP, Fuentes-Ahumada C, Oros-Ovalle C, Navarrete-Solis J, Moncada B. Histochemical and immunohistochemical study in melasma: evidence of damage in the basal membrane. Am J Dermatopathol. 2011 May;33(3):291-5. doi: 10.1097/DAD.0b013e3181ef2d45.

    PMID: 21317614BACKGROUND

MeSH Terms

Conditions

Hyperpigmentation

Interventions

DesonideNiacinamidenicomidecetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bertha Torres-Alvarez, MD

    Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto", San Luis Potosi, México

    STUDY CHAIR

  • Gabryela N Larraga-Piñones, MD

    Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México

    PRINCIPAL INVESTIGATOR

  • Juan P Castanedo-Cázares, MD

    Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatology research director

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 2, 2012

Study Start

July 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

ME(1)