Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream

NCT01562470 | Completed Phase 1

• 1 other identifier: 10-104-002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Study Hypothesis: That the test product will reduce thigh cellulite more that the placebo. This will be a double-blind, placebo-controlled study involving subjects with distinctive cellulite appearance on both thighs. Subjects will apply test cream to one thigh and placebo to the other, by random allocation, and cellulite appearance will be measured at week 0, 8 and 16. Cellulite photographs will also be assessed by a (study blinded) trial researcher, who will assess cellulite appearance on a precisely-measured upper leg area. The subjects' own perception of cellulite appearance, from their diaries, will be numerically coded, and all three measures will be collated and analysed statistically.

Conditions

Thigh Cellulite

Keywords

cellulite; reduction; cream; thighs; women

Outcome Measures

Primary Outcomes (1)

• thigh cellulite appearance

  Reduction of cellulite appearance, as assessed by photographs, self-assessment and clinician assessment.

  16 weeks

Secondary Outcomes (2)

• Uper leg circumference and fat content

  16 weeks

• Presence/absence of adverse reactions

  16 weeks

Study Arms (1)

herbal-based cellulite cream

EXPERIMENTAL

Trial subjects will apply the treatment cream to one thigh and placebo to the other thigh, by random allocation.

Other: Cellulite reduction cream

Interventions

Cellulite reduction cream OTHER

1/8 tsp cellulite cream will be applied to the thigh twice daily - in the morning and at night, for a period of 16 weeks.

herbal-based cellulite cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \>18 years
• Cellulite present equally on both thighs
• Willing to apply cream, as directed, for 16 weeks
• Willing to maintain habitual diet throughout the trial
• Willing to refrain from making any lifestyle changes during the life of the trial (exercise regimes, specific diets or cleanses)
• Will to refrain from making any changes to smoking habits during the study period
• Participant is in good health on the basis of medical history
• Participant understands the study procedures and provides informed consent (signed) to participate and authorizes the release of relevant protected health information to the study investigators

You may not qualify if:

• Use of medications known to influence cellulite appearance
• Any leg surgical visit scheduled during trial
• Known intolerance or sensitivity to any ingredients in the study product
• Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
• Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.

Sponsors & Collaborators

• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: lead

Study Sites (1)

Nutrasource Diagnostics Inc.

Guelph, Ontario, N1H1Y3, Canada

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Traplin, MD

  Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

  STUDY DIRECTOR

• Maggie Laidlaw, Ph.D.

  Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: March 23, 2012
• Study Start: June 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

CA (1)