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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05885035
Other study ID # KD2019
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 1, 2023
Est. completion date June 26, 2023

Study information

Verified date July 2023
Source K. Kay Durairaj, MD, FACS, A Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the efficacy of Calcium Hydroxylapatite (CaHA) in treating cellulite dimples in the buttocks. Participants will: - have 3 treatment sessions at weeks 0, 4, and 8 and a final live assessment visit at week 14 - receive approximately 2 syringes per side of the buttocks, per treatment session - have their pictures taken before and after each treatment session, and once more during the final visit


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Calcium Hydroxyapatite
Each syringe of CaHA contains 1.5 cc of product, and it will be diluted 1:1 with 1.0 cc of normal saline solution and 0.5 cc of 1% Lidocaine with a ratio of 1:100,000 epinephrine in the target sites.

Locations

Country Name City State
United States K. Kay Durairaj, MD, FACS, A Medical Corporation Pasadena California

Sponsors (2)

Lead Sponsor Collaborator
Kalpna Kay Durairaj, MD, FACS Merz North America, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Outcome

Type Measure Description Time frame Safety issue
Primary Global Aesthetic Improvement Scale (GAIS) Rating The treating physician will rate the subject after the final treatment. Based on aesthetic appearance, qualitative success of treatment will be evaluated using the GAIS. Aesthetic appearance will be rated one of the five following options:
Worse: The appearance is worse than the original condition
No Change: The appearance is essentially the same as the original condition
Improved: Obvious improvement in appearance from the initial condition, but a touchup or re-treatment is indicated
Much Improved: Marked improvement in appearance but not completely optimal for this patient. A touchup would slightly improve the result
Very Much Improved: Optimal cosmetic result for the treatment in this patient
Up to 14 weeks
Primary Cellulite Severity Scale (CSS) Rating The treating physician and the blinded, secondary physician will rate the subject after the final treatment. The scale identifies 5 key clinical morphologic features of cellulite: (1) number of evident depressions, (2) depth of depressions, (3) morphologic appearance of skin surface alterations, (4) grade of laxity, flaccidity, or sagging skin, and (5) the classification scale originally described by Nurnberger and Muller. The scale has 4 points to describe each feature of cellulite: Stage 0 is no dimpling in relaxed or contracted states, Stage 1 implies no dimpling upon relaxed states but dimpling during muscle contraction or skin pinching, Stage 2 implies dimpling appears spontaneously when standing but not when lying down, and Stage 3 implies dimpling is spontaneously present when both standing and lying down and is evident to the naked eye. Up to 14 weeks
Secondary Global Aesthetic Improvement Scale (GAIS) Rating Based on aesthetic appearance, qualitative success of treatment will be evaluated by the treating physician using the GAIS. Aesthetic appearance will be rated one of the five following options:
Worse: The appearance is worse than the original condition
No Change: The appearance is essentially the same as the original condition
Improved: Obvious improvement in appearance from the initial condition, but a touchup or re-treatment is indicated
Much Improved: Marked improvement in appearance but not completely optimal for this patient. A touchup would slightly improve the result
Very Much Improved: Optimal cosmetic result for the treatment in this patient
Up to 8 weeks
Secondary Global Aesthetic Improvement Scale (GAIS) Rating Based on aesthetic appearance, qualitative success of treatment will be self-evaluated by subjects using the GAIS. Aesthetic appearance will be rated one of the five following options:
Worse: The appearance is worse than the original condition
No Change: The appearance is essentially the same as the original condition
Improved: Obvious improvement in appearance from the initial condition, but a touchup or re-treatment is indicated
Much Improved: Marked improvement in appearance but not completely optimal for this patient. A touchup would slightly improve the result
Very Much Improved: Optimal cosmetic result for the treatment in this patient
Up to 14 weeks
Secondary Cellulite Severity Scale (CSS) Rating The treating physician and the blinded, secondary physician will rate the subject at each treatment visit using the CSS Rating. The scale identifies 5 key clinical morphologic features of cellulite: (1) number of evident depressions, (2) depth of depressions, (3) morphologic appearance of skin surface alterations, (4) grade of laxity, flaccidity, or sagging skin, and (5) the classification scale originally described by Nurnberger and Muller. The scale has 4 points to describe each feature of cellulite: Stage 0 is no dimpling in relaxed or contracted states, Stage 1 implies no dimpling upon relaxed states but dimpling during muscle contraction or skin pinching, Stage 2 implies dimpling appears spontaneously when standing but not when lying down, and Stage 3 implies dimpling is spontaneously present when both standing and lying down and is evident to the naked eye. Up to 8 weeks
Secondary Patient Satisfaction of Aesthetic Appearance Subjects will rate their satisfaction of aesthetic appearance of their buttocks at each treatment and at the final assessment. Patient satisfaction will be assessed using a 5-point scale: (1) extremely dissatisfied, (2) dissatisfied, (3) slightly satisfied, (4) satisfied, and (5) extremely satisfied. Up to 14 weeks
Secondary Patient Treatment Satisfaction Subjects will rate their satisfaction of the treatment at each treatment visit and at the final assessment. Patient satisfaction will be assessed using a 5-point scale: (1) extremely dissatisfied, (2) dissatisfied, (3) slightly satisfied, (4) satisfied, and (5) extremely satisfied. Up to 14 weeks
Secondary Telephone Assessment Subjects will be contacted weekly to assess safety injection site and treatment responses. Questionnaire will consist of the 5 following questions:
How are you feeling?
What (if any) side effects are you experiencing?
Are you experiencing pain as a result of treatment?
Are you following the post-procedural instructions?
Do you have any questions or concerns?
Up to 14 weeks
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